COOK CODA BALLOON CATHETER

K032869 · Cook, Inc. · DQY · Nov 19, 2003 · Cardiovascular

Device Facts

• Record ID: K032869
• Device Name: COOK CODA BALLOON CATHETER
• Applicant: Cook, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The COOK CODA™ BALLOON CATHETER is intended for temporary occlusion of large vessels, or to expand vascular prostheses.

Device Story

The Cook Coda Balloon Catheter is a 2-lumen percutaneous catheter used for temporary large vessel occlusion or vascular prosthesis expansion. The device features a distal lumen for tracking over a .035-inch guidewire and a secondary lumen for balloon inflation/deflation. Radiopaque bands at the proximal and distal ends of the balloon facilitate positioning under fluoroscopic guidance. The device is operated by a physician in a clinical setting. By inflating the balloon, the clinician achieves vessel occlusion or prosthesis expansion, potentially benefiting patients by facilitating vascular interventions. The device is supplied sterile in double pouches.

Clinical Evidence

Bench testing only. Testing assessed biocompatibility, mechanical properties, performance characteristics, and safety. The device met all pre-defined test criteria.

Technological Characteristics

2-lumen percutaneous catheter; balloon diameters 30-40 mm; lengths 100-120 cm; radiopaque positioning bands; compatible with .035-inch guidewire; sterile, double-pouch packaging.

Indications for Use

Indicated for temporary occlusion of large vessels or expansion of vascular prostheses in patients requiring such procedures.

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

• LDOB BALLOON CATHETER (K002286)
• ILIAC BALLOON CATHETER (K003495)

Submission Summary (Full Text)

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| 510(k) Summary | NOV 1 9 2003 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Theodore Heise, PhD, RAC<br>Director of Regulatory Scientific Affairs<br>Cook Incorporated<br>750 N. Daniels Way<br>Bloomington, IN 47404<br>[phone]<br>September 12, 2003 |
| Names of Device: | |

COOK CODA™ BALLOON CATHETER Trade Name: Common/Usual Name: Balloon catheter Classification Name: Percutaneous catheter

# Intended Use:

The COOK CODA™ BALLOON CATHETER is intended for temporary occlusion of large vessels, or to expand vascular prostheses.

## Predicate Devices:

Predicate devices are the LDOB BALLOON CATHETER (K002286) manufactured by Cook Incorporated (vessel occlusion), and the ILIAC BALLOON CATHETER (K003495) manufactured by Guidant Corporation (prosthesis expansion).

### Device Description:

The COOK CODA™ BALLOON CATHETER is a 2-lumen catheter. The distal lumen extends the length of the catheter for use over a ,035 wire quide. The other lumen communicates with the balloon and is used to expand and deflate it. Radiopaque bands are placed at both the distal and proximal aspects of the balloon to assist with positioning of the device under fluoroscopy. The balloon will be provided in diameters ranging from 30 to 40 mm, and in lengths ranging from 100 to 120 cm. The device is packaged in sterile, sealed double pouches.

#### Substantial Equivalence:

The COOK CODA™ BALLOON CATHETER is comparable with respect to technical characteristics and intended use to predicate devices in terms of 510(k) substantial equivalence.

#### Discussion of Tests and Test Results:

The COOK CODA™ BALLOON CATHETER underwent testing to assess biocompatibility, mechanical properties, performance characteristics, and safety, The device met the test criteria, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence.

#### Conclusions Drawn from Tests:

The COOK CODA™ BALLOON CATHETER met the test criteria, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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NOV 1 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Theodore Heise Director of Regulatory Scientific Affairs c/o Cook Incorporated P.O. Box 489 Bloomington, IN 47402-0489

Re: K032869 CODA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 12, 2003 Received: September 15, 2003

Dear Dr. Heise:

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.

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.

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Page 2 – Dr. Theodore Heise

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.

Arlile B. Boam

for

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

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known) __ K03 2869

COOK CODA BALLOON CATHETER

Indications for Use:

Device Name:

The COOK CODA BALLOON CATHETER is intended for temporary occlusion of large vessels, or to expand vascular prostheses.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ashley B. Boane

Division Sign-Off
Division of Cardiovascular Devices

510(k) Number k032869

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