Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon dilatation catheter, with no mention of AI or ML.

Therapeutic

Yes
The device is intended to dilate stenoses in arteries and treat arteriovenous dialysis fistulae, which are therapeutic actions. It is also indicated for stent dilatation post-deployment, another therapeutic intervention.

Diagnostic

No

Explanation: The device is a balloon dilatation catheter used to treat stenoses (narrowing) in arteries and for stent dilatation. Its purpose is interventional (treatment), not diagnostic (identifying a condition). The description explicitly states it does not incorporate a lumen for distal dye injections or distal pressure measurements, which are diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical balloon dilatation catheter with various hardware components (shaft, lumens, Y-hub manifold, luer lock fittings, guide wire insertion). It is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device used to physically dilate blood vessels and treat fistulae. This is a therapeutic procedure performed directly on the patient's body.
Device Description: The description details a balloon catheter designed for percutaneous transluminal angioplasty (PTA). This involves inserting the device into the body to perform a mechanical action.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a therapeutic purpose.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Parafleet SC 014 / Parafleet SC 035 is intended to dilate stenoses in the iliac. femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae.

This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

Product codes

LIT

Device Description

The Parafleet balloon dilatation catheter family consists of Parafleet SC 014, Parafleet SC 018 and Parafleet SC 035 PTA balloon catheter. The PTA (OTW type) device is an over the wire (OTW) peripheral balloon catheter, specially designed for Percutaneous Transluminal Angioplasty (PTA). The Parafleet SC catheter is available in working lengths of 40cm, 90cm, 120cm, 150cm and 200cm, with balloon diameters ranging from 1.25mm to 12.0mm. The Parafleet features an outer tube and inner tube lumen shaft ending in a Y-hub manifold with luer lock fittings. One lumen is used for inflation of the balloon and accessed via the side leg port. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for a standard 0.014 inch / 0.018 inch / 0.035 inch guide wire insertion. The catheter is sterilized with EO and for single use only. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, arteriovenous dialysis fistulae, peripheral vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Standard bench performance tests were conducted to confirm substantial equivalence between the Subject Device and the Predicate Devices.
The in vitro performance tests were conducted on subject device in accordance with FDA guidance 'Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions, Guidance for Industry and FDA Staff', including:

Dimensional verification
Simulated Use
Balloon Rated Burst Pressure
Balloon Fatigue
Balloon Compliance
Balloon Inflation and Deflation Time
Catheter Bond Strength
Tip Pull Strength
Flexibility and Kinking
Torque Strength
Radiopacity
Coating Friction
Coating Integrity
Particulate Evaluation
Catheter Body Bust Pressure
Balloon Rated Burst Pressure (in stent)
Balloon Fatigue (in stent)
A Biocompatibility Testing

The biocompatibility testing, conducted in accordance "Use of International Standard ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", and International Standard "ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process", as recognized by FDA, included:

Cytotoxicity
Sensitization
Intracutaneous Reactivity
Systemic Toxicity
Hemocompatibility
- Hemolysis
- Thrombosis
- Complement Activation
Pyrogenicity

The test results met all acceptance criteria, were same or similar to the predicate devices, and ensure that the Parafleet SC 014 / Parafleet SC 018 / Parafleet SC 035 PTA Balloon Dilatation Catheter design and construction are suitable for its intended use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K160256

Reference Device(s)

K192318, K142261, K102035

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).

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.

February 27, 2025

BrosMed Medical Co., Ltd. Crystal Lee Registration and Clinical Medicine Department Manager 15th Building, SMEs Venture Park SongShan Lake Hi-Tech Industrial Development Zone Dongguan, Guangdong 523808 China

Re: K243704

Trade/Device Name: Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: November 28, 2024 Received: November 29, 2024

Dear Crystal Lee:

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 (QS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 mediation-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-regulatory

2

assistance/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,

ARIEL G. ASH- Digitally signed by ARIEL
SHAKOOR -S G. ASH-SHAKOOR -S
Date: 2025.02.27 10:00:55
-05'00'

For

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

Enclosure

3

Indications for Use

510(k) Number (if known) K243704

Device Name Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter

Indications for Use (Describe)

The Parafleet SC 014 / Parafleet SC 035 is intended to dilate stenoses in the iliac. femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae.

This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)

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4

510(k) SUMMARY

1. GENERAL INFORMATION

1.1 Submitter

BrosMed Medical Co., Ltd. 15th Buildings, SMEs Venture Park SongShan Lake Hi-Tech Industrial Development Zone Dongguan 523808, China Office: +86 (769) 2289 2018 Fax: +86 (769) 2289 2016

1.2 Contract person

Crystal Lee, Email: crystallee@brosmed.com Office: +86 (769) 2289 2018

1.3 Date of Preparation January 24, 2025

2. NAME OF THE DEVICE

2.1.1 Trade/Proprietary Name Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter;

2.1.2 Common/Usual Name Percutaneous Transluminal Angioplasty (PTA) Catheter

2.1.3 Classification Information

Classification Name:	Percutaneous Catheter
Classification Regulation:	21 CFR 870.1250
Device Class:	Class II
Product Code:	LIT
Review Panel:	Cardiovascular

3. PREDICATE DEVICE AND REFERENCE DEVICES

. Primary Predicate Device: Polux, Minerva, Atropos PTA Balloon Catheter (K160256, cleared on July 29, 2016)
Reference Devices: . Ultraverse 014 and 018 PTA Balloon Dilatation Catheters (K192318, cleared on October 3, 2019) Ultraverse 035 PTA Balloon Dilatation Catheter (K142261, cleared on September 24, 2014) Sleek OTW PTA Catheter (K102035, cleared on December 1, 2010)

DESCRIPTION OF THE DEVICE 4.

The Parafleet balloon dilatation catheter family consists of Parafleet SC 014, Parafleet SC 018 and Parafleet SC 035 PTA balloon catheter. The PTA (OTW type) device is an over the wire (OTW) peripheral balloon catheter, specially designed for Percutaneous Transluminal Angioplasty (PTA). The

5

Parafleet SC catheter is available in working lengths of 40cm, 90cm, 120cm, 150cm and 200cm, with balloon diameters ranging from 1.25mm to 12.0mm. The Parafleet features an outer tube and inner tube lumen shaft ending in a Y-hub manifold with luer lock fittings. One lumen is used for inflation of the balloon and accessed via the side leg port. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for a standard 0.014 inch / 0.018 inch / 0.035 inch guide wire insertion. The catheter is sterilized with EO and for single use only. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

న. INDICATION FOR USE

The Parafleet SC 014 / Parafleet SC 018 / Parafleet SC 035 is intended to dilate stenoses in the illiac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

COMPARISION SUMMARY WITH PREDICATE DEVICES 6.

The information of subject devices and predicate devices summarized as below Table 1.

Table 1 Subject Device & Predicate Devices

| Trade Name | Parafleet SC
014, Parafleet
SC 018,
Parafleet SC
035 PTA
Balloon
Dilatation
Catheter

Proposed
device | Polux, Minerva,
Atropos PTA
Balloon
Dilatation
Catheter
Predicate
device | Ultraverse 014
and 018 PTA
Balloon
Dilatation
Catheters
Reference
device | Ultraverse 035
PTA Balloon
Dilatation
Catheter
Reference
device | Sleek OTW
PTA Catheter
-Reference
device |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------|
| 510(K) Number | K243704 | K160256 | K192318,
K121856,
K093965 | K142261 | K102035 |
| Owner/Operator | BrosMed
Medical Co.,
Ltd | BrosMed
Medical Co.,
Ltd | Bard Peripheral
Vascular, Inc | Bard Peripheral
Vascular, Inc | Clear Stream
Technologies,
Ltd |

The subject devices have the following similarities to the predicate devices:

Same principle of operation
Same mechanism of action ●
Same indication for use
Same sterilization method
Same balloon size
Similar materials
. Similar device components

Please see below Table 2 and Table 3 for the comparison between Subject devices and Predicate devices.

6

Element of	Proposed	Predicate	Reference	Reference	Reference	Judgement
Comparison	device	device	device	device	device
Product
Name	Parafleet SC
014, Parafleet
SC 018,
Parafleet SC
035	Polux,
Minerva,
Atropos	Ultraverse
014 and 018	Ultraverse
035	Sleek	/
Product
Code	LIT	LIT	LIT	LIT	LIT	Same
Regulation
Number	870.1250	870.1250	870.1250	870.1250	870.1250	Same
Device
Name	Catheter,
Angioplasty,
Peripheral,
Transluminal	Catheter,
Angioplasty,
Peripheral,
Translumina	Catheter,
Angioplasty,
Peripheral,
Transluminal	Catheter,
Angioplasty,
Peripheral,
Transluminal	Catheter,
Angioplasty,
Peripheral,
Transluminal	Same
Target Area	Peripheral
arteries and
arteriovenous
dialysis
fistulae	Peripheral
arteries and
arteriovenous
dialysis
fistulae	Peripheral
arteries and
arteriovenous
dialysis
fistulae	Peripheral
arteries and
arteriovenous
dialysis
fistulae	Peripheral
arteries and
arteriovenous
dialysis
fistulae	Same
Intended
use	The Parafleet
SC 014/
Parafleet SC
018/ Parafleet
SC 035 is
intended to
dilate
stenoses in
the iliac,
femoral,
iliofemoral,
popliteal,
infrapopliteal
, and renal
arteries, and
for the
treatment of
obstructive
lesions of
native or
synthetic
arteriovenous
dialysis
fistulae. This
device is also
indicated for
stent
dilatation	Polux,
Minerva,
Atropos are
indicated to
dilate
stenoses in
the iliac,
femoral,
iliofemoral,
popliteal,
infrapopliteal,
and renal
arteries, and
for the
treatment of
obstructive
lesions of
native or
synthetic
arteriovenous
dialysis
fistulae. This
device is also
indicated for
dilatation of
post-
deployed
stent in the	Ultraverse
014 and
Ultraverse
018 PTA
Balloon
Dilatation
Catheters are
recommended
for use in
percutaneous
trasluminal
angioplasty
(PTA) of the
renal,
popliteal,
tibial,
femoral, and
peroneal
arteries.
These
catheters are
not for use in
coronary
arteries.	The
Ultraverse
035 PTA
Dilatation
Catheter is
intended to
dilate
stenoses in
the peripheral
arteries, to
treat
obstructive
lesions of
native or
synthetic AV
fistulae
and/or re-
expand
endoluminal
stent graft
elements in
the iliac
arteries. This
device is also
recommended
for post-
dilatation of
balloon
expandable	Balloon
dilatation of
the femoral,
popliteal, and
infra-
popliteal
arteries.
These
catheters are
not designed
to be used in
the coronary
arteries.	Same with
Polux,
Minerva,
Atropos
post-
deployment
in the
peripheral
vasculature.	peripheral
vasculature.	and self-
expanding
stents in the
peripheral
vasculature.
This catheter
is not for use
in coronary
arteries.

Table 2 General and Intended Use Comparison

7

8

| Technological
Characteristic Parafleet SC 014, Parafleet
SC 018, Parafleet SC 035 Polux, Minerva, Atropos
( shaft, strain relief, hub.
Over-the-Wire (OTW)
design | Consists balloon, catheter shaft, strain
relief, hub.
Over-the-Wire (OTW) design | Compatible Guidewire
(in) | 0.014, 0.018, 0.035 Minerva, Atropos);
0.014, 0.018 (Ultraverse 014
and 018)
0.035 (Ultraverse 035) | Compatible Sheath (F) Atropos);
4, 5, 6 (Ultraverse 014 and 018)
5, 6, 7 (Ultraverse 035) | Balloon Compliance
Type | Semi-Compliant | Balloon Diameter Range
(mm) | 1.25-12.0 Atropos);
1.5-9.0 (Ultraverse 014 and 018)
3.0-12.0 (Ultraverse 035)
1.25-5.0 (Sleek) | Balloon Length Range
(mm) | 10-300 Atropos);
20-300 (Ultraverse 014 and 018)
20-300 (Ultraverse 035) | Catheter Working
Length (cm) | 40-200 Atropos);
75-200 (Ultraverse 014 and 018)
75-130 (Ultraverse 035) | Nominal Pressure (atm) | Rated Burst Pressure
(atm) | 12-16 11-16 (Ultraverse 014 and 018)
10-14 (Ultraverse 035) | Radio-detectability | Biological Characteristics | Tip device
Parafleet SC 035: Equivalent |
| Balloon Tubing | Catheter Shaft Equivalent |
| Coating | Sterilization Method | Proposed Device
| Predicate/ Reference Devices
nolitics.com/search/K160256" target="_blank" rel="noopener noreferrer" class="text-primary hover:underline">K160256), Ultraverse 014 and
k.innolitics.com/search/K192318" target="_blank" rel="noopener noreferrer" class="text-primary hover:underline">K192318, K121856,
olitics.com/search/K093965" target="_blank" rel="noopener noreferrer" class="text-primary hover:underline">K093965), Ultraverse 035
nolitics.com/search/K142261" target="_blank" rel="noopener noreferrer" class="text-primary hover:underline">K142261), and Sleek (K102035) | Judgement |
--------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
Specification | | | |
| Consists of tip, marker
of tip, marker bands,
| Same |
| 0.014, 0.018, 0.035 (Polux,
| Same |
| 4, 5, 6, 7 | 4, 5, 6, 7 (Polux, Minerva,
| Same |
| Semi-Compliant | Same |
| 1.5-10.0 (Polux, Minerva,
| Same |
| 5-200 (Polux, Minerva,
| Similar |
| 40-150 (Polux, Minerva,
| Similar |
| 6 | 6 | Same |
| 14 (Polux, Minerva, Atropos);
| Similar |
| Yes | Yes | Same |
| | | |
| Parafleet SC 014 and Parafleet SC 018: Same as predicate
Similar to predicate device | | Substantially
| Same as predicate device | | Same |
| Similar to predicate device | | Substantially
| Same as predicate device | | Same |
| Ethylene Oxide (EtO) | | Same |

Table 3 Technological Comparison of Subject Device and Predicate Devices

9

7. PERFORMANCE TESTING SUMMARY

Standard bench performance tests were conducted to confirm substantial equivalence between the Subject Device and the Predicate Devices.

> Bench Testing

The in vitro performance tests were conducted on subject device in accordance with FDA guidance 'Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions, Guidance for Industry and FDA Staff', including:

Dimensional verification
Simulated Use ●
Balloon Rated Burst Pressure ●
Balloon Fatigue
Balloon Compliance
Balloon Inflation and Deflation Time ●
Catheter Bond Strength
Tip Pull Strength
Flexibility and Kinking
Torque Strength
. Radiopacity
Coating Friction ●
Coating Integrity
Particulate Evaluation ●
Catheter Body Bust Pressure
Balloon Rated Burst Pressure (in stent)
. Balloon Fatigue (in stent)
A Biocompatibility Testing

The biocompatibility testing, conducted in accordance "Use of International Standard ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", and International Standard "ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process", as recognized by FDA, included:

. Cytotoxicity
Sensitization ●
Intracutaneous Reactivity ●
Systemic Toxicity
Hemocompatibility ●
- Hemolysis
- Thrombosis ●
- . Complement Activation
Pyrogenicity ●

10

> Sterilization Packaging and Shelf Life

The test results met all acceptance criteria, were same or similar to the predicate devices, and ensure that the Parafleet SC 014 / Parafleet SC 018 / Parafleet SC 035 PTA Balloon Dilatation Catheter design and construction are suitable for its intended use.

CONCLUSION 8.

The information presented in this 510(k) submission demonstrates that the Parafleet SC 014, Parafleet SC 018, and Parafleet SC 035 are Substantially Equivalent (SE) to the marketed predicate devices described above.