OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302

K022145 · LeMaitre Vascular, Inc. · DXE · Jan 14, 2003 · Cardiovascular

Device Facts

• Record ID: K022145
• Device Name: OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
• Applicant: LeMaitre Vascular, Inc.
• Product Code: DXE · Cardiovascular
• Decision Date: Jan 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LeMaitre Over The Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.

Device Story

Over The Wire Embolectomy Catheter (Model 2302) is a mechanical surgical device used by physicians for vascular procedures. It functions as a catheter for removing emboli and thrombi from blood vessels. The device is designed for use over a guidewire, facilitating precise placement within the vasculature. Beyond clot removal, it supports clinical utility for vessel occlusion, fluid infusion, and aspiration. It is operated by clinicians in a surgical or interventional setting. The device provides a mechanical means to restore blood flow by clearing obstructions, directly benefiting patients suffering from embolic or thrombotic events.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical embolectomy catheter; over-the-wire design; Class II device (21 CFR 870.5150); product code 74 DXE.

Indications for Use

Indicated for removal of emboli and thrombi during embolectomy and/or thrombectomy procedures. Also indicated for guidewire-assisted catheter placement, vessel occlusion, fluid infusion, and aspiration.

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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 4 2003

LeMaitre Vascular Inc. Mr. James Ashby Quality Assurance Specialist 26 Ray Avenue Burlington, MA 01803

Re: K022145

> Trade/Device Name: Over The Wire Embolectomy Catheter, Model 2302 Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: 74 DXE Dated: October 16, 2002 Received: October 21, 2002

Dear Mr. Ashby:

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

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Page 2 - Mr. James Ashby

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 vours.

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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510(k) Number (if known): Device Name: LeMaitre Vasculor's Over The Wire Enbalectiony Castletter Indications For Use:

The LeMultire Over The Wire Embolectiony Cathefer is indicated for use in the removed of emboli and Thrombi c dufme embolectional and/or thism bectumy. It can also be used for cadheder placement over a guidentire, vessel occlusion, fluid indusion and/or asgiradion .

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number *16022145*
(Optional For

(Optional Format 3-10-98)