(147 days)
The LeMaitre Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi.
Not Found
This looks like a 510(k) clearance letter from the FDA for a medical device called the "LeMaitre Embolectomy Catheter." This type of document does not contain the information requested about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert details for AI/device performance evaluation.
510(k) clearances are primarily based on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. While manufacturers submit data to support their claims, the detailed study information as requested is not typically included in the final clearance letter itself. These letters acknowledge the submission and state the FDA's finding of substantial equivalence.
Therefore, I cannot provide the requested information from the provided text.
{0}------------------------------------------------
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
{1}------------------------------------------------
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 (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{2}------------------------------------------------
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
§ 870.5150 Embolectomy catheter.
(a)
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.(b)
Classification. Class II (performance standards).