CORDIS EXTREME PTA BALLOON CATHETER

K992825 · Cordis Corp. · LIT · Sep 15, 1999 · Cardiovascular

Device Facts

• Record ID: K992825
• Device Name: CORDIS EXTREME PTA BALLOON CATHETER
• Applicant: Cordis Corp.
• Product Code: LIT · Cardiovascular
• Decision Date: Sep 15, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PowerFlex Extreme PTA balloon catheter is indicated for dilatation of stenoses in iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

Dual lumen PTA balloon catheter; distal inflatable balloon; two radiopaque marker bands for placement visualization. Used by clinicians for percutaneous transluminal angioplasty to dilate arterial stenoses or treat dialysis fistula obstructions. Device functions via mechanical inflation of balloon to restore vessel patency. Benefits include improved blood flow in peripheral vasculature and dialysis access sites.

Clinical Evidence

Bench testing only; safety and effectiveness demonstrated via non-clinical design verification tests and analyses.

Technological Characteristics

Dual lumen catheter design; distal inflatable balloon; radiopaque marker bands for positioning. Biocompatible materials. Mechanical inflation mechanism.

Indications for Use

Indicated for patients requiring dilatation of stenoses in iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, or 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

• Cordis PowerFlex Plus PTA Balloon Catheter

Submission Summary (Full Text)

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POWERFLEXTM EXTREME PTA Catheter Cordis Corporation, a Johnson & Johnson Company

K99282\$

510(k) Premarket Notification

| Appendix C | |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Safety and Effectiveness | |
| Submitter: | Cordis Corporation, a Johnson and Johnson Company<br>40 Technology Drive<br>Warren, New Jersey 07059 |
| | Telephone: [phone]<br>Fax: [phone] |
| Contact<br>Person: | Karen Wilk<br>Senior Associate, Regulatory Affairs<br>Cordis Corporation, a Johnson and Johnson Company<br>40 Technology Drive<br>Warren, New Jersey 07059 |
| | Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | August 20, 1999 |
| General<br>Provisions | Trade Name: Cordis PowerFlex ^™ Extreme PTA Balloon Catheter<br>Common Name: Peripheral Transluminal Angioplasty Balloon Catheter<br>Classification Name: CFR 870.1250 Percutaneous Catheter |
| Device<br>Classification | Class II. |
| Name of<br>Predicate<br>Devices | Cordis PowerFlex ^™ Plus PTA Balloon Catheter |
| Performance<br>Standards | Performance standards have not been established by the FDA under section<br>514 of the Food, Drug and Cosmetic Act. |

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| Intended Use<br>and Device<br>Description | The PowerFlex Extreme PTA balloon catheter is indicated for dilatation of<br>stenoses in iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal<br>arteries, and for the treatment of obstructive lesions of native or synthetic<br>arteriovenous dialysis fistulae. |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Cordis PowerFlex Extreme PTA balloon catheter is a dual lumen design<br>with a distal inflatable balloon. Two radiopaque marker bands indicate the<br>dilating section of the balloon and aid in the balloon placement. |
| Biocompatibility: | All materials used in the PowerFlex Extreme PTA balloon catheter are<br>biocompatible. |
| Performance<br>Data: | The safety and effectiveness of the Cordis PowerFlex Extreme PTA Balloon<br>Catheter have been demonstrated via data collect from non-clinical design<br>verification tests and analyses. |
| Summary of<br>Substantial<br>Equivalence | The PowerFlex Extreme PTA Balloon Catheter is substantially equivalent to<br>the previously cleared PowerFlex Plus PTA Balloon Catheters. |

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a bird or other winged creature.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 1999

Ms. Karen Wilk Cordis Corp. 40 Technology Drive Warren, NJ 07059

K992825 Re: Cordis PowerFlex EXTREME Percuataneous Transluminal Angioplasty (PTA) Balloon Catheter Regulatory Class: II (two) Product Code: 74 LIT Dated: August 20, 1999 Received: August 23, 1999

Dear Ms. Wilk:

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 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 (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 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 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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Page 2 - Ms. Karen Wilk

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/dsma/dsmamain.html".

Sincerely yours

Thomas J. Callehan

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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Special 510(k) Number:

长992825

Device Name:

## Cordis PowerFlex EXTREME Percuataneous Transluminal Angioplasty (PTA) Balloon Catheter

Indication For Use:

The Cordis PowerFlex EXTREME PTA Balloon Catheter is indicated for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off) for Callahan
Division of Cardiovascular and Respiratory Devices

510(k) Number K992825

510(k) Number