LEMAITRE EMBOLECTOMY CATHETER

K992368 · Vascutech, Inc. · DXE · Dec 9, 1999 · Cardiovascular

Device Facts

• Record ID: K992368
• Device Name: LEMAITRE EMBOLECTOMY CATHETER
• Applicant: Vascutech, Inc.
• Product Code: DXE · Cardiovascular
• Decision Date: Dec 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LeMaitre Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi.

Device Story

The LeMaitre Embolectomy Catheter is a surgical instrument used by physicians to remove arterial emboli and thrombi. The device is inserted into the arterial system to mechanically retrieve clots. It functions as a manual tool for vascular intervention, allowing the clinician to clear obstructions and restore blood flow. It is used in clinical or surgical settings. The device provides a mechanical solution for embolectomy, directly benefiting patients by resolving arterial blockages.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Mechanical embolectomy catheter; manual operation; intended for arterial use. Specific materials and dimensions not detailed in the provided text.

Indications for Use

Indicated for the removal of arterial emboli and thrombi in patients requiring embolectomy or thrombectomy procedures.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 1999

Mr. Trent G. Kamke Vice President-Operations Vascutech, Inc. 164 Middlesex Turnpike Burlington, MA 01803

Re : K992368 Trade Name: LeMaitre Embolectomy Catheter Requlatory Class: II Product Code: DXE September 28, 1999 Dated: Received: September 29, 1999

Dear Mr. Kamke:

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 Requlations, 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 Requlation (QS) for Medical Devices: General requlation (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 requlation may result in requlatory 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 obliqation you might have under sections 531 through 542 of the Act for devices

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Page 2 - Mr. Trent G. Kamke

under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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" (21CFR 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,

Cuitgylu. Ah for

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INDICATIONS FOR USE

| Device Name | LeMaitre Embolectomy Catheter |
|-------------|-------------------------------|
|-------------|-------------------------------|

- The LeMaitre Embolectomy Catheter is indicated for the removal Indications for Use of arterial emboli and thrombi.
Autograph for Witten

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K992368 510(k) Number