LeMaitre Retrograde Valvulotome

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K924171 ↗

FDA Product Code

MGZ

Device Class

Class II

Regulation

21 CFR Part 870.4885

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lemaitre Irrigation Catheter

  Class II

  FDA 510(k) K992933 Active Cleared 8 Mar 2000

• LeMaitre Occlusion Catheter

  Class II

  FDA 510(k) K992942 Active Cleared 13 Apr 2000

• Lemaitre-Bookwalter Vessel Devices

  Class II

  FDA 510(k) K912548 Active Cleared 18 Sep 1991

• Lemaitre Embolectomy Catheter Open recall

  Class II

  FDA 510(k) K992368 Active Cleared 9 Dec 1999

• Lemaitre Balloon Catheter with Irrigation

  Class II

  FDA 510(k) K992940 Active Cleared 22 Feb 2000

• The Samuels Retrograd Valvulotome

  Class II

  FDA 510(k) K932009 Active Cleared 21 Sep 1993

See all devices from Vascutech, Inc. →

• What is the LeMaitre Retrograde Valvulotome used for?

  The LeMaitre Retrograde Valvulotome is used for valve cutting in cardiovascular procedures, providing a specific solution for this medical need.

• Is the LeMaitre Retrograde Valvulotome a single-use or reusable device?

  The device description does not explicitly state whether it is single-use or reusable, but its classification as a class 2 device suggests it may be reusable with proper sterilization.

• What regulatory clearance does the LeMaitre Retrograde Valvulotome have?

  The LeMaitre Retrograde Valvulotome has been granted FDA 510K clearance, indicating it is substantially equivalent to a predicate device.

• How is the LeMaitre Retrograde Valvulotome supplied?

  The device is supplied by Vascutech, Inc., and its distribution is regulated under the specified product code and regulation number.