PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS

K971010 · Cordis Corp. · LIT · Jun 18, 1997 · Cardiovascular

Device Facts

• Record ID: K971010
• Device Name: PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS
• Applicant: Cordis Corp.
• Product Code: LIT · Cardiovascular
• Decision Date: Jun 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Savvy PTA Catheters are designed for dilating stenotic atherosclerotic lesions in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and illo femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

Savvy PTA Catheter is a percutaneous transluminal angioplasty device used by physicians to dilate stenotic atherosclerotic lesions in peripheral arteries and obstructive lesions in arteriovenous dialysis fistulae. The device consists of a catheter with an inflatable balloon at the distal end. During a procedure, the physician inserts the catheter into the vasculature, navigates to the target lesion, and inflates the balloon to mechanically dilate the vessel or fistula. This restores blood flow and relieves obstruction. The device is used in clinical settings (e.g., interventional radiology or vascular surgery suites).

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, construction, and performance characteristics. Biocompatibility testing was performed.

Technological Characteristics

Percutaneous transluminal angioplasty catheter featuring an inflatable balloon for mechanical dilation. Device is classified as Class II. Biocompatibility testing performed per regulatory requirements.

Indications for Use

Indicated for balloon dilatation of stenotic atherosclerotic lesions in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, ilio femoral) and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae.

Regulatory Classification

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.

Predicate Devices

• Savvy PTA Catheters (Cordis Corporation)
• Opta 5 PTA Catheters (Cordis Corporation)
• Ultra Thin PTA Catheter (Meditech)

Submission Summary (Full Text)

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K971010
June 18, 1997

# PREMARKET NOTIFICATION 510(k)
Cordis Corporation
Savvy PTA Catheters
March 19, 1997

## SUMMARY OF SAFETY AND EFFECTIVENESS

### I. General Provisions:

Common Name: Percutaneous Transluminal Angioplasty Catheters
Proprietary Name: Savvy PTA Catheters

### II. Name of Predicate Devices:

1. Trade Name: Savvy PTA Catheters
Manufacturer: Cordis Corporation

2. Trade Name: Opta 5 PTA Catheters
Manufacturer: Cordis Corporation

3. Trade Name: Ultra Thin PTA Catheter
Manufacturer: Meditech

### III. Classification:

Class II

### IV. Performance Standards:

Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.

### V. Intended Use and Device Description:

Savvy PTA Catheters are designed for dilating stenotic atherosclerotic lesions in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and illo femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

### VI. Biocompatibility

All appropriate biocompatibility tests were successfully performed on Cordis Corporation’s Savvy PTA Catheters.

### VII. Summary of Substantial Equivalence:

Savvy PTA Catheters are substantially equivalent to the predicate devices. Savvy PTA Catheters are similar in design, construction, indications for use, and performance characteristics as compared to commercially available PTA Catheters.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUN 18 1997

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Jodi Lynn Greenizen
Regulatory and Clinical Affairs Associate
Cordis Corporation
P.O. Box 025700
Miami, Florida 33102-5700

Re: K971010
Cordis Savvy PTA Catheter
Regulatory Class: II (two)
Product Code: LIT
Dated: March 17, 1997
Received: March 20, 1997

Dear Ms. Greenizen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class II (Special Controls) or 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 requirement, 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 Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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PREMARKET NOTIFICATION 510(K)
Cordis Corporation
Savvy PTA Catheters

# INDICATIONS FOR USE

510(k) Number: K971010

Device Name: Cordis Savvy PTA Balloon Catheter

Indications for Use: The Cordis PTA Catheters are intended for balloon dilatation of lesions in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and ilio femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.


(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K971010

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE AS NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over - The Counter Use