BARD CONQUEST PTA BALLOON DILATATION CATHETER

K014212 · C.R. Bard, Inc. · DQY · Jan 17, 2002 · Cardiovascular

Device Facts

• Record ID: K014212
• Device Name: BARD CONQUEST PTA BALLOON DILATATION CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bard® Conquest™ PTA Balloon Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

Device Story

The Bard® Conquest™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter featuring a balloon at its distal tip. It is designed for use by physicians in clinical settings to perform percutaneous transluminal angioplasty. The device includes two radiopaque marker bands beneath the balloon to facilitate accurate positioning within the vasculature under imaging. One lumen is used for guidewire insertion, while the second lumen serves as a channel for balloon inflation and deflation. By inflating the balloon at the site of an obstructive lesion, the device dilates the vessel or fistula, thereby improving blood flow. The device is intended for peripheral vascular applications and is explicitly contraindicated for coronary artery use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Coaxial lumen catheter; balloon mounted on distal tip; two radiopaque marker bands; shaft diameters of 6, 7, or 8 Fr; shaft lengths of 50, 75, or 100 cm. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty of femoral, iliac, or renal arteries, and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae. Contraindicated for use in coronary arteries.

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

• Opti-Plast Centurion™ 5.5 Fr PTA Catheter

Submission Summary (Full Text)

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Bard Peripheral Technologies C.R. Bard, Inc. 13183 Harland Dr., N.E. Covington, GA 30014

K014212

JAN 1 7 2002

# BARD

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENES INFORMATION

- A.. Submitter Information:

| Submitter's Name: | C.R. Bard, Inc., Peripheral Technologies Division |
|------------------------------------|---------------------------------------------------|
| Submitter's Address: | 13183 Harland Drive, Covington, GA 30014 |
| Contact Person: | Carol Vierling |
| Contact Person's Telephone Number: | [phone] |
| Contact Person's FAX Number: | [phone] |
| Date of Preparation: | December 14, 2001 |

- B. Device Name:
Bard® Conquest™ PTA Balloon Dilatation Catheter

- C. Predicate Device:
Opti-Plast Centurion™ 5.5 Fir PTA Catheter

- D. Device Description: ·
The Bard® Conquest™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion guidewire and the second provides a channel for inflation/deflation of the balloon. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature.

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#### E. Intended Use:

The Bard® Conquest™ PTA Balloon Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

- F. Technological Characteristics Summary:
The Bard® Conquest™ PTA Balloon Dilatation Catheter is offered in 6, 7 or 8 Fr shaft diameters and shaft lengths of 50, 75 or 100cm, depending on balloon size. Various balloon diameters and lengths are available.

- G. Performance Data:
Bench testing shows that the modified catheter is substantially equivalent to the predicate device, the Opti-Plast Centurion™ 5.5 Fr PTA Catheter.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three wavy lines representing the flow of life. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 1 7 2002

Ms. Carol Vierling Director, Regulatory Affairs C.R. Bard, Inc. Bard Peripheral Technologies 13183 Harland Drive, N.E. Covington, GA 30014

Re: K014212

Trade Name: Bard® Conquest™ PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: December 14, 2001 Received: December 21, 2001

Dear Ms. Vierling:

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 (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. 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 - Ms. Carol Vierling

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Dallas Miller

ram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Device Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ATTACHMENT 5

# Indications for Use Statement

| Device<br>Name | Bard® ConquestTM PTA Balloon Dilatation Catheter |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| Indications<br>for Use | The Bard® ConquestTM PTA Balloon Dilatation Catheter<br>is recommended for use in Percutaneous Transluminal Angioplasty of the<br>femoral, iliac and renal arteries and for the treatment of obstructive lesions<br>of native or synthetic arteriovenous dialysis fistulae. This catheter is not<br>for use in coronary arteries. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

N
Division of Cardiovascular & Respiratory Devices
510(k) Number 2617212

Prescription Use
(Per 21 CFR 801.109

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________