LMI THROMBECTOMY CATHETER

K970657 · Lucas Medical, Inc. · DXE · Jul 1, 1997 · Cardiovascular

Device Facts

• Record ID: K970657
• Device Name: LMI THROMBECTOMY CATHETER
• Applicant: Lucas Medical, Inc.
• Product Code: DXE · Cardiovascular
• Decision Date: Jul 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LMI Thrombectomy Catheter is intended for use in venous thrombectomy procedures for intra-operative removal of venous thrombus formations from veins.

Device Story

LMI Thrombectomy Catheter is a mechanical device used for intra-operative removal of venous thrombus. Operated by physicians in an OR setting. Device functions by physical extraction of thrombus from veins. Benefits include restoration of venous blood flow. No software or electronic components involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical catheter for venous thrombectomy. No energy source, software, or electronic components. Sterilization method not specified.

Indications for Use

Indicated for patients requiring intra-operative removal of venous thrombus formations during venous 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Daniel R. Lucas
President
Lucas Medical, Inc.
1751 S. Douglass Road
Anaheim, California 92806

JUL 1 1997

Re: K970657
LMI Thrombectomy Catheter
Regulatory Class: II (two)
Product Code: DXE
Dated: May 23, 1997
Received: May 28, 1997

Dear Mr. Lucas:

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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulation may result in regulatory 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 obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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" (21 CFR 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/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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LUCAS MEDICAL, INC.

# INDICATIONS FOR USE

The LMI Thrombectomy Catheter is intended for use in venous thrombectomy procedures for intra-operative removal of venous thrombus formations from veins.


(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970657

1751 S. Douglass Rd. Anaheim, CA. 92806 Phone: [phone] Fax: [phone]