The 7F Catheter is a 65 cm dual lumen catheter which consists of an injection lumen that allows for saline to be injected and an exhaust lumen that allows for the fluid to be transported into a collection bag.

AI/ML Overview

This is a 510(k) premarket notification for the Cordis 7F Hydrolyser Thrombectomy Catheter, which received substantial equivalence on February 26, 1999. The device is indicated for the percutaneous removal of soft, newly formed (≤ 5 days old) thrombus from dialysis shunts.

While the document confirms the device's substantial equivalence to predicate devices and mentions "pre-clinical and clinical testing" to confirm this equivalence, it does not provide detailed acceptance criteria or the specific results of those studies. Therefore, I cannot construct a table of acceptance criteria and reported device performance, nor can I answer the questions about sample sizes, ground truth establishment, or specific study designs (MRMC, standalone).

The document is a regulatory approval letter and a summary of safety and effectiveness, which typically provides high-level information rather than detailed study protocols and results.

Summary

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October 8, 2021

Cordis Corp. Ariel MacTavish Sr. Regulatory Affairs Associate 14201 N.w.60th Ave. Miami Lakes, Florida 33014

Re: K983534

Trade/Device Name: Cordis 7F Hydrolyser Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ

Dear Ariel MacTavish:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 26, 1999. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory. Oconnell(a)FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.10.08 10:41:10 -04'00'

Gregory O'Connell 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

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle with three stylized wing segments.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 26 1999

Ariel MacTavish, RAC Senior Regulatory Affairs Associate Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014

Re : K983534 R983931
Trade Name: 7F Hydrolyser Thrombectomy Catheter Regulatory Class: II Product Code: DXE Dated: January 11, 1999 Received: January 12, 1999

Dear Ms. MacTavish:

We have reviewed your Section 510(k) notification of intent to market the we nave referenced above and we have determined the device is device referenced as a maications for use stated in the subscanctarly equivalent (195 entry marketed in interstate encrosure) to regarly manison the enactment date of the Medical Device Commerce prior co na cer that have been reclassified in accordance with Amendmentby, or oo ace al Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls may, chereises, maact. The general controls provisions of the Act provisions or one one for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special r four lor class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to Federal Register.

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Page 2 - Ms. Ariel MacTavish

your premarket notification submission does not affect any obligation you your premarked nocerrouseers in through 542 of the Act for devices under might nave under become one on the provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in IIIS fecter will arrow Jourseaus.
This fected will arrow Jourseling. The FDA finding of substantial your 510(K) premaired notifications in the expedicate device results equivalence of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation If you desire bpcording and additionally 809.10 for in vitro diagnostic (21 Crk Fart over and addressions)
devices), please contact the Office of Compliance at (301) 594-4586. devices), predbe consult on the promotion and advertising of your Additionally, 102 quobered on Compliance at (301) 594-4639. Also, action promote the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on premarked nover the Act may be obtained from the Division of your responsible to the toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahah Director Division of Cardiovascular, Respiratory And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 3

Indications for Use Statement

510(k) Number (if known)
Device Name	Cordis 7F Hydrolyser Thrombectomy Catheter
Indications for Use	The 7F Hydrolyser is indicated to percutaneously remove soft, newly formed (≤ 5 days old) thrombus from dialysis shunts.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number _

Prescription Use _ (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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2/26/99

00-00028 K983134

Attachment 1

Summary of Safety and Effectiveness

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GeneralProvisions	The name of the device is:
	Proprietary Name	Common or Usual Name
	Cordis 7F Hydrolyser Thrombectomy Catheter	Embolectomy Catheter
Name ofPredicateDevices	The device is substantially equivalent to:Angiodynamics PRO™ Infusion Catheter used in conjunction witha thrombolytic agent, such as Urokinase, in a pulse-spraythrombolytic procedure Arrow-Trerotola™ Percutaneous Thrombolytic Device Catheter, inconjunction with the Arrow Rotator Drive Unit
Classification	Class II.
PerformanceStandards	Performance standards have not been established by the FDA undersection 514 of the Food, Drug and Cosmetic Act.
Indications forUse	The 7F Hydrolyser is indicated to percutaneously remove soft, newlyformed (≤ 5 days old) thrombus from dialysis shunts.
DeviceDescription	The Cordis 7F Hydrolyser Thrombectomy Catheter system consists ofa 7F Catheter and an Accessory Kit.The 7F Catheter is a 65 cm dual lumen catheter which consists of aninjection lumen that allows for saline to be injected and an exhaustlumen that allows for the fluid to be transported into a collection bag.
Biocompatibility	All materials used in the Cordis 7F Hydrolyser ThrombectomyCatheter are biocompatible.
Summary ofSubstantialEquivalence	The Cordis 7F Hydrolyser Thrombectomy Catheter is substantiallyequivalent to the predicate devices. The equivalence was confirmedthrough pre-clinical and clinical testing.

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).