The reprocessed Cordis Catheters are available in a broad variety of French sizes and configurations. These catheters combine an atraumatic tip with a braided body.

AI/ML Overview

The provided text describes the 510(k) summary for Reprocessed Cordis Super Torque and Super Torque Plus Diagnostic Angiographic Catheters. This document is a premarket notification for a medical device and thus does not contain information about studies related to AI or ground truth as it pertains to AI/ML models. Instead, it focuses on demonstrating substantial equivalence to predicate devices through functional and safety testing.

Here's the relevant information based on the provided text, adapted for the requested format where applicable, and noting where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Tests Conducted	Reported Device Performance
Biocompatibility	Cytotoxicity, Hemocompatibility, Sensitization, Irritation, Systemic Toxicity	Not explicitly detailed in terms of specific numeric results. The document states "Bench and laboratory testing was conducted to demonstrate substantially equivalent performance." Implies that the reprocessed device met established biocompatibility standards.
Cleaning Validation	(Implicit based on reprocessing nature)	Not explicitly detailed in terms of specific numeric results. The document states "reprocessing of these devices includes removal of visible soil and decontamination." Implies validation demonstrated effective cleaning to specified standards.
Sterilization Validation	(Implicit based on reprocessing nature)	Not explicitly detailed in terms of specific numeric results. Implies validation demonstrated effective sterilization to specified standards.
Functional Testing	Visual Inspection, Dimensional Verification, Radiopacity Testing, Simulated Use Testing, Leak Testing, Torsion Testing, Tip Buckling Testing, Tensile Testing, Coating Coverage, Particulate Testing	Not explicitly detailed in terms of specific numeric results. The document states "Bench and laboratory testing was conducted to demonstrate substantially equivalent performance." Implies the reprocessed device met established functional performance standards in these areas.
Packaging Validation	(Implicit)	Not explicitly detailed in terms of specific numeric results. Implies validation demonstrated effective packaging to maintain sterility and integrity.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each of the listed functional and safety tests. It generally refers to "Bench and laboratory testing." It is a regulatory submission for a reprocessed medical device, not an AI/ML study. Therefore, the concept of "test set" in the context of AI/ML models, data provenance (country of origin), and retrospective/prospective data collection is not applicable here. The testing would have been performed on samples of the reprocessed devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. The device is a physical medical device (angiographic catheter), and "ground truth" as it relates to expert-labeled data for an AI/ML model is not relevant to this submission. The "ground truth" in this context would be the established performance specifications for diagnostic angiographic catheters, and the testing validates that the reprocessed device meets those specifications.

4. Adjudication Method for the Test Set

This information is not applicable, as it pertains to expert consensus on AI/ML model outputs, which is not relevant for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable as this is a physical medical device (angiographic catheter) and does not involve AI or human readers evaluating images or data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is a physical medical device and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance criteria would be the established performance specifications and safety standards for diagnostic angiographic catheters as defined by relevant industry standards (e.g., ISO, ASTM) and FDA guidance for these types of devices and for reprocessed devices. This includes physical properties, biocompatibility, sterility, and functional performance. It is based on engineering specifications and scientific testing standards, not expert consensus on medical images or pathology.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/ML model; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" for this physical medical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 1, 2024

Innovative Health, LLC. Amanda Babcock Regulatory Affairs Manager 1435 North Hayden Road Suite 100 Scottsdale, Arizona 85257

Re: K231015

Trade/Device Name: Reprocessed Cordis Super Torque and Super Torque Plus Diagnostic Angiographic Catheters Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: NLI Dated: April 7, 2023 Received: April 10, 2023

Dear Amanda Babcock:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Ariel Ariel G. Ash-G. Ash-shakoor -S Date: 2024.07.01 09:21:23 shakoor -S -04'00'

For

Gregory O'Connell

{2}------------------------------------------------

Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K231015

Device Name

Reprocessed Cordis Super Torque and Super Torque Plus Angiographic Diagnostic Catheters

Indications for Use (Describe)

Reprocessed Cordis Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) SUMMARY

Submitter's Name and Address:

Innovative Health, LLC. 1435 N. Hayden Road, Suite 100 Scottsdale, AZ 85257

Contact Name and Information:

Meerna Muradvich Regulatory Affairs Engineer Innovative Health, LLC. (480) 692-7176 (office) (888) 965-7706 (fax) mmuradvich@innovative-health.com

Amanda Babcock Regulatory Affairs Manager Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7706 (fax) ababcock@innovative-health.com

Date prepared:

06/26/2024

Device Information:

Trade/Proprietary Name:	Reprocessed Cordis Super Torque and SuperTorque Plus Diagnostic Angiographic Catheters
Common Name:	Angiographic Catheter
Classification Name:	Catheter, Angiography, Reprocessed
Classification Number:	Class II, 21 CFR 870.1200
Product Code:	NLI

Predicate Device:

510(k) Number	Device	Manufacturer
K915836	Cordis 5.0 French Super Torque Catheters	Cordis Corp.
K914007	Cordis 5.2 French Super Torque Plus	Cordis Corp.

Device Description:

The reprocessed Cordis Catheters are available in a broad variety of French sizes and configurations. These catheters combine an atraumatic tip with a braided body.

The item numbers included in the scope of this submission are as follows:

Description	ItemNumber	FrenchSize	Length	Sideholes	Curve
	532-410T	4	65	8	PIG
	532-420T	4	65	8	straight
	532-462	4	65	2	RDCS
Description	Item Number	French Size	Length	Side holes	Curve
ReprocessedCordis SuperTorqueDiagnosticAngiographicCatheter	532-444	4	65	0	C3
	532-445	4	65	2	C3
	532-473	4	65	0	SHK 1
	532-474	4	65	0	SHK 2
	532-447	4	65	0	JC 1
	532-448	4	65	0	JC 2
	532-449	4	65	0	JC 3
	SR3740	4	80	0	JL 1.5
	SRD6054	4	80	0	JL 2
	SR4533	4	80	0	JL 2.5
	SRD6920	4	80	4	PIG 145°
	532-432	4	80	2	multipurpose small
	532-478	4	80	2	RDCS
	532-411T	4	90	8	PIG
	532-421T	4	90	8	straight
	SRD5816	4	100	0	IM-MOD-5
	532-412T	4	100	8	PIG
	532-422T	4	100	8	straight
	532-430	4	100	0	multipurpose small
	532-482	4	100	2	multipurpose small
	532-414	4	100	0	SIM 1
	532-415	4	100	0	SIM 2
	532-461	4	100	0	H1
	532-470	4	100	0	MAN
	532-405	4	100	0	BERN
	532-436	4	100	0	JB1
	532-437	4	100	0	JB2
	532-438	4	100	0	JB3
	532-497	4	100	0	VERT
	532-413T	4	110	8	PIG
	532-524V8	5	65	8	PIG
	532-564V8	5	65	8	straight
	532-576	5	65	0	multipurpose (subintimalrecanalization)
	532-510	5	65	2	RDCS
	532-514	5	65	0	C3
	532-517	5	65	2	C3
	532-519	5	65	0	SHK 1
	532-522	5	65	0	JC 2
	532-523	5	65	0	JC 3
	532-579	5	80	0	MPA
Description	ItemNumber	FrenchSize	Length	Sideholes	Curve
	532-511	5	80	2	RDCS
	532-509	5	80	0	RDCA
	532-567	5	80	0	SHK 2
	532-539F8	5	90	8	PIG
	532-555H8	5	100	8	PIG
	532-569H8	5	100	8	straight
	532-578	5	100	0	MPA
	532-501	5	100	0	SIM 1
	532-546	5	100	2	SIM 1
	532-502	5	100	0	SIM 2
	532-547	5	100	2	SIM 2
	532-503	5	100	0	SIM 3
	532-504	5	100	0	H1
	532-520	5	100	0	HN4
	532-571	5	100	0	MAN
Reprocessed	532-541H0	5	100	0	JB1
Cordis Super	532-543H0	5	100	0	JB2
Torque	532-549H0	5	100	0	VERT
Diagnostic	455-610T	6	65	12	PIG
AngiographicCatheter	455-672	6	65	0	C3
	455-689	6	80	2	RDCA
	455-698	6	80	4	NIH
	532-506	6	80	2	multipurpose small
	455-623	6	80	0	MPA
	455-636	6	80	2	MPA
	455-686	6	80	0	RDCA
	455-611T	6	90	12	PIG
	532-618	6	100	0	JL 3.5
	532-620	6	100	0	JL 4
	532-627	6	100	0	JL 4.5
	532-622	6	100	0	JL 5
	532-624	6	100	0	JL 6
	532-645	6	100	0	AL 1
	532-646	6	100	0	AL 2
	532-647	6	100	0	AL 3
	532-619	6	100	0	JR 3.5
	532-621	6	100	0	JR 4
	532-623	6	100	0	JR 5
	532-625	6	100	0	JR 6
	532-648	6	100	0	AR MOD
	532-642	6	100	2	MPA 2
Description	ltemNumber	FrenchSize	Length	Sideholes	Curve
	532-649	ర్	100	2	MPB 2
	532-640	6	100	0	SON 1
	532-664	6	100	4	SON 2
	532-672	6	100	0	LCB
	532-670	ರಿ	100	0	RCB
	532-660	6	100	0	IM
Reprocessed	455-637	6	100	2	MPA
Cordis Super	455-660	6	100	0	SIM 1
Torque	455-660D	6	100	2	SIM 1
Diagnostic	455-661	6	100	0	SIM 2
Angiographic	455-662	6	100	0	ടിM 3
Catheter	455-663	6	100	0	SIM 4
	455-665	6	100	0	H1
	455-666	6	100	0	H1
	532-650S	6	110	6	PIG
	532-652S	6	110	6	PIG 145°
	532-654S	ರಿ	110	6	PIG 145° MOD
	455-613E	රි	110	8	PIG
Reprocessed	533-562	5.2	65	2	MPA 2
Cordis Super	533-579	5.2	80	0	MPA
Torque PlusDiagnostic	SR3216	5.2	100	0	JL 3
Angiographic	533-551	5.2	100	0	JL 3.5
Catheter	233-223	5.2	100	0	JL 4
	533-527	5.2	100	0	JL 4.5
	233-229	5.2	100	0	ി 5
	533-561	5.2	100	0	JL 6
	533-542	5.2	100	0	AL 2
	533-544	5.2	100	O	AL 3
	SR4615	5.2	100	O	XB 3.5 ST
	233-250	5.2	100	O	JR 3.5
	533-552	5.2	100	O	JR 4
	533-528	5.2	100	0	JR 4 MOD
	533-563	5.2	100	0	JR 4 ST
	533-558	5.2	100	0	JR 5
	533-560	5.2	100	O	JR 6
	SR1924	5.2	100	O	MPA
	533-582	5.2	100	2	MPA 2
	533-584	5.2	100	O	CAS 1
	533-585	5.2	100	0	CAS 2
	59950072	5.2	100	2	RBL-JK
	599500T1	5.2	100	1	RBL-TG
Description	ItemNumber	FrenchSize	Length	Sideholes	Curve
	533-572	5.2	100	0	LCB
	533-570	5.2	100	0	RCB
	533-580	5.2	100	0	IM
	SR4658	5.2	100	0	IM-MOD
	SR4268	5.2	100	0	IM-MOD-2
	SR4685	5.2	100	0	IM-MOD-3
	533-533	5.2	110	6	PIG
	533-534A	5.2	110	6	PIG 145°
ReprocessedCordis SuperTorque PlusDiagnostic	533-537S	5.2	110	6	PIG 145° MOD
	533-533A	5.2	110	6	PIG 155°
	533-633	6	80	0	MPA 1
	533-629	6	80	2	MPA 2
	533-682	6	80	4	CAS 2
	533-635	6	80	0	NIH
	533-618	6	100	0	JL 3.5
	533-620	6	100	0	JL 4
	533-627	6	100	0	JL 4.5
	533-622	6	100	0	JL 5
	533-624	6	100	0	JL 6
	533-645	6	100	0	AL 1
	533-646	6	100	0	AL 2
	533-647	6	100	0	AL 3
	533-619	6	100	0	JR 3.5
	533-621	6	100	2	JR 3.5
	533-687	6	100	0	JR 4 CLASSIC
	533-689	6	100	0	JR 4 RECESSEDBRAIDING
	533-628	6	100	0	JR 4 MOD
	533-626	6	100	0	JR 4 ST
	533-623	6	100	0	JR 5
	533-625	6	100	0	JR 6
	533-648	6	100	0	AR MOD
	533-641	6	100	0	AR 1 MOD
	533-643	6	100	0	AR 2 MOD
	533-640	6	100	0	MPA 1 COURNAD
	533-642	6	100	2	MPA 2
	533-649	6	100	2	MPB 2
	533-634	6	100	6	MPB 3
	533-630	6	100	4	SON 1
	533-631	6	100	0	SON 2
	533-632	6	100	4	SON 3
Description	ItemNumber	FrenchSize	Length	Sideholes	Curve
ReprocessedCordis SuperTorque PlusDiagnosticAngiographicCatheter	533-684	6	100	0	CAS 1
	533-685	6	100	0	CAS 2
	533-686	6	100	0	CAS 3
	599600R401	6	100	1	RBL 4.0
	599600R451	6	100	1	RBL 4.5
	599600R501	6	100	1	RBL 5.0
	599600J2	6	100	2	RBL-JK
	599600T1	6	100	1	RBL-TG
	533-637	6	100	0	EGB 1
	533-638	6	100	0	EGB 2
	533-672	6	100	0	LCB
	533-670	6	100	0	RCB
	533-660	6	100	0	IM
	533-636	6	100	0	NIH
	533-650F	6	110	4	PIG
	533-650S	6	110	6	PIG
	533-650E	6	110	8	PIG
	533-652S	6	110	6	PIG 145°
	533-653S	6	110	6	PIG 145° MOD
	533-654S	6	110	6	PIG 155°
	533-655S	6	110	6	PIG 155° MOD

{5}------------------------------------------------

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

Table 1: Device Scope

Indications for Use:

Reprocessed Cordis Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.

Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Cordis Super Torque and Super Torque Plus diagnostic angiographic catheters are identical to the predicate devices. There are no changes to the claims, clinical applications, patient population, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of these devices includes removal of visible soil and decontamination. Each device is inspected and function tested prior to packaging and labeling.

Functional and Safety Testing:

Bench and laboratory testing was conducted to demonstrate substantially equivalent performance of the Reprocessed Cordis Super Torque and Super Torque Plus Catheters. This included the following:

{10}------------------------------------------------

Biocompatibility ●
- Cytotoxicity .
- Hemocompatibility
- Sensitization
- . Irritation
- . Systemic Toxicitv
Cleaning Validation ●
Sterilization Validation
Functional testing ●
- Visual Inspection .
- . Dimensional Verification
- l Radiopacity Testing
- l Simulated Use Testing
- . Leak Testing
- I Torsion Testing
- Tip Buckling Testing I
- 트 Tensile Testing
- . Coating Coverage
- . Particulate Testing
. Packaging Validation

The Reprocessed Cordis Super Torque and Super Torque Plus Catheters are reprocessed no more than one (1) time. Each device is marked, serialized and tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing. Reprocessing is performed only by Innovative Health. Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.

Conclusion:

Innovative Health concludes that the Reprocessed Cordis Super Torque and Super Torque Plus Diagnostic Angiographic catheters do not raise new questions of safety and effectiveness and supports substantial equivalence to the predicate devices described herein.

{11}------------------------------------------------

Description	ItemNumber	FrenchSize	Length	Sideholes	Curve
	532-410T	4	65	8	PIG
	532-420T	4	65	8	straight
	532-462	4	65	2	RDCS
	532-444	4	65	0	C3
	532-445	4	65	2	C3
	532-473	4	65	0	SHK 1
	532-474	4	65	0	SHK 2
	532-447	4	65	0	JC 1
	532-448	4	65	0	JC 2
	532-449	4	65	0	JC 3
	SR3740	4	80	0	JL 1.5
	SRD6054	4	80	0	JL 2
	SR4533	4	80	0	JL 2.5
	SRD6920	4	80	4	PIG 145°
	532-432	4	80	2	multipurpose small
	532-478	4	80	2	RDCS
	532-411T	4	90	8	PIG
	532-421T	4	90	8	straight
ReprocessedCordis SuperTorqueDiagnosticAngiographicCatheter	SRD5816	4	100	0	IM-MOD-5
	532-412T	4	100	8	PIG
	532-422T	4	100	8	straight
	532-430	4	100	0	multipurpose small
	532-482	4	100	2	multipurpose small
	532-414	4	100	0	SIM 1
	532-415	4	100	0	SIM 2
	532-461	4	100	0	H1
	532-470	4	100	0	MAN
	532-405	4	100	0	BERN
	532-436	4	100	0	JB1
	532-437	4	100	0	JB2
	532-438	4	100	0	JB3
	532-497	4	100	0	VERT
	532-413T	4	110	8	PIG
	532-524V8	5	65	8	PIG
	532-564V8	5	65	8	straight
	532-576	5	65	0	multipurpose (subintimalrecanalization)
	532-510	5	65	2	RDCS
Description	ItemNumber	FrenchSize	Length	Sideholes	Curve
	532-514	5	65	0	C3
	532-517	5	65	2	C3
	532-519	5	65	0	SHK 1
	532-522	5	65	0	JC 2
	532-523	5	65	0	JC 3
	532-579	5	80	0	MPA
	532-511	5	80	2	RDCS
	532-509	5	80	0	RDCA
	532-567	5	80	0	SHK 2
	532-539F8	5	90	8	PIG
	532-555H8	5	100	8	PIG
	532-569H8	5	100	8	straight
	532-578	5	100	0	MPA
	532-501	5	100	0	SIM 1
	532-546	5	100	2	SIM 1
	532-502	5	100	0	SIM 2
	532-547	5	100	2	SIM 2
	532-503	5	100	0	SIM 3
	532-504	5	100	0	H1
	532-520	5	100	0	HN4
ReprocessedCordis SuperTorqueDiagnosticAngiographicCatheter	532-571	5	100	0	MAN
	532-541H0	5	100	0	JB1
	532-543H0	5	100	0	JB2
	532-549H0	5	100	0	VERT
	455-610T	6	65	12	PIG
	455-672	6	65	0	C3
	455-689	6	80	2	RDCA
	455-698	6	80	4	NIH
	532-506	6	80	2	multipurpose small
	455-623	6	80	0	MPA
	455-636	6	80	2	MPA
	455-686	6	80	0	RDCA
	455-611T	6	90	12	PIG
	532-618	6	100	0	JL 3.5
	532-620	6	100	0	JL 4
	532-627	6	100	0	JL 4.5
	532-622	6	100	0	JL 5
	532-624	6	100	0	JL 6
	532-645	6	100	0	AL 1
	532-646	6	100	0	AL 2
Description	ItemNumber	FrenchSize	Length	Sideholes	Curve
ReprocessedCordis SuperTorqueDiagnosticAngiographicCatheter	532-647	6	100	0	AL 3
	532-619	6	100	0	JR 3.5
	532-621	6	100	0	JR 4
	532-623	6	100	0	JR 5
	532-625	6	100	0	JR 6
	532-648	6	100	0	AR MOD
	532-642	6	100	2	MPA 2
	532-649	6	100	2	MPB 2
	532-640	6	100	0	SON 1
	532-664	6	100	4	SON 2
	532-672	6	100	0	LCB
	532-670	6	100	0	RCB
	532-660	6	100	0	IM
	455-637	6	100	2	MPA
	455-660	6	100	0	SIM 1
	455-660D	6	100	2	SIM 1
	455-661	6	100	0	SIM 2
	455-662	6	100	0	SIM 3
	455-663	6	100	0	SIM 4
	455-665	6	100	0	H1
	455-666	6	100	0	H1
	532-650S	6	110	6	PIG
	532-652S	6	110	6	PIG 145°
	532-654S	6	110	6	PIG 145° MOD
	455-613E	6	110	8	PIG
ReprocessedCordis SuperTorque PlusDiagnosticAngiographicCatheter	533-562	5.2	65	2	MPA 2
	533-579	5.2	80	0	MPA
	SR3216	5.2	100	0	JL 3
	533-551	5.2	100	0	JL 3.5
	533-553	5.2	100	0	JL 4
	533-527	5.2	100	0	JL 4.5
	533-559	5.2	100	0	JL 5
	533-561	5.2	100	0	JL 6
	533-542	5.2	100	0	AL 2
	533-544	5.2	100	0	AL 3
	SR4615	5.2	100	0	XB 3.5 ST
	533-550	5.2	100	0	JR 3.5
	533-552	5.2	100	0	JR 4
	533-528	5.2	100	0	JR 4 MOD
	533-563	5.2	100	0	JR 4 ST
Description	Item Number	French Size	Length	Side holes	Curve
	533-558	5.2	100	0	JR 5
	533-560	5.2	100	0	JR 6
	SR1924	5.2	100	0	MPA
	533-582	5.2	100	2	MPA 2
	533-584	5.2	100	0	CAS 1
	533-585	5.2	100	0	CAS 2
	599500J2	5.2	100	2	RBL-JK
	599500T1	5.2	100	1	RBL-TG
	533-572	5.2	100	0	LCB
	533-570	5.2	100	0	RCB
	533-580	5.2	100	0	IM
	SR4658	5.2	100	0	IM-MOD
	SR4268	5.2	100	0	IM-MOD-2
	SR4685	5.2	100	0	IM-MOD-3
	533-533	5.2	110	6	PIG
	533-534A	5.2	110	6	PIG 145°
ReprocessedCordis SuperTorque PlusDiagnosticAngiographicCatheter	533-537S	5.2	110	6	PIG 145° MOD
	533-533A	5.2	110	6	PIG 155°
	533-633	6	80	0	MPA 1
	533-629	6	80	2	MPA 2
	533-682	6	80	4	CAS 2
	533-635	6	80	0	NIH
	533-618	6	100	0	JL 3.5
	533-620	6	100	0	JL 4
	533-627	6	100	0	JL 4.5
	533-622	6	100	0	JL 5
	533-624	6	100	0	JL 6
	533-645	6	100	0	AL 1
	533-646	6	100	0	AL 2
	533-647	6	100	0	AL 3
	533-619	6	100	0	JR 3.5
	533-621	6	100	2	JR 3.5
	533-687	6	100	0	JR 4 CLASSICJR 4 RECESSED
	533-689	6	100	0	BRAIDING
	533-628	6	100	0	JR 4 MOD
	533-626	6	100	0	JR 4 ST
	533-623	6	100	0	JR 5
	533-625	6	100	0	JR 6
	533-648	6	100	0	AR MOD
Description	ItemNumber	FrenchSize	Length	Sideholes	Curve
ReprocessedCordis SuperTorque PlusDiagnosticAngiographicCatheter	533-641	6	100	0	AR 1 MOD
	533-643	6	100	0	AR 2 MOD
	533-640	6	100	0	MPA 1 COURNAD
	533-642	6	100	2	MPA 2
	533-649	6	100	2	MPB 2
	533-634	6	100	6	MPB 3
	533-630	6	100	4	SON 1
	533-631	6	100	0	SON 2
	533-632	6	100	4	SON 3
	533-684	6	100	0	CAS 1
	533-685	6	100	0	CAS 2
	533-686	6	100	0	CAS 3
	599600R401	6	100	1	RBL 4.0
	599600R451	6	100	1	RBL 4.5
	599600R501	6	100	1	RBL 5.0
	599600J2	6	100	2	RBL-JK
	599600T1	6	100	1	RBL-TG
	533-637	6	100	0	EGB 1
	533-638	6	100	0	EGB 2
	533-672	6	100	0	LCB
	533-670	6	100	0	RCB
	533-660	6	100	0	IM
	533-636	6	100	0	NIH
	533-650F	6	110	4	PIG
	533-650S	6	110	6	PIG
	533-650E	6	110	8	PIG
	533-652S	6	110	6	PIG 145°
	533-653S	6	110	6	PIG 145° MOD
	533-654S	6	110	6	PIG 155°
	533-655S	6	110	6	PIG 155° MOD

The item numbers included in the scope of this submission are as follows:

{12}------------------------------------------------

{13}------------------------------------------------

{14}------------------------------------------------

{15}------------------------------------------------

Table 1: Device Scope

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).