DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)

K032041 · LeMaitre Vascular, Inc. · DWF · Aug 27, 2003 · Cardiovascular

Device Facts

• Record ID: K032041
• Device Name: DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
• Applicant: LeMaitre Vascular, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Aug 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Distal Perfusion Catheter is intended for use as a temporary perfusion conduit to allow blood flow to the distal arteries during open abdominal and thoracoabdominal aortic aneurysm repair.

Device Story

Distal Perfusion Catheter functions as temporary conduit for blood flow to distal arteries during open abdominal and thoracoabdominal aortic aneurysm repair. Device provides perfusion to distal vasculature while aorta is clamped; prevents ischemic injury. Used in surgical setting by vascular surgeons. Device is mechanical catheter; no electronic or software components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical catheter for temporary perfusion. Class II device (21 CFR 870.4210). No electronic, software, or energy-based components.

Indications for Use

Indicated for patients undergoing open abdominal and thoracoabdominal aortic aneurysm repair requiring temporary distal arterial perfusion.

Regulatory Classification

Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with three horizontal bars above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2003

Lemaitre Vascular Inc. c/o Mr. Carlos Chaparro Lemaitre Vascular Inc. 3101 37th Avenue St. Petersburg, FL 33713

> K032041 Distal Perfusion Catheter Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF Dated: June 30, 2003 Received: July 11, 2003

Dear Mr. Chaparro:

Re:

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 - Mr. Carlos Chaparro

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), 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,

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

The Distal Perfusion Catheter is intended for use as a temporary perfusion conduit to allow blood flow to the distal arteries during open abdominal and thoracoabdominal aortic aneurysm repair.

(Division S-Off)
Division of Cardiovascular Devices
510(k) number K032041