LeMaitre Occlusion Catheter

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

510(k) Number

K992942 ↗

FDA Product Code

MJN

Device Class

Class II

Regulation

21 CFR Part 870.4450

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lemaitre Irrigation Catheter

  Class II

  FDA 510(k) K992933 Active Cleared 8 Mar 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

• Sterile LeMaitre Glow 'N Tell Tape

  Class II

  FDA 510(k) K932184 Active Cleared 22 Jul 1993

See all devices from Vascutech, Inc. →

• What is the primary clinical use of the LeMaitre Occlusion Catheter?

  This device is an intravascular catheter designed to provide temporary vessel occlusion. It is specifically indicated for the control of both arterial and venous bleeding.

• Is this device authorized for clinical use?

  Yes, the LeMaitre Occlusion Catheter is authorized under FDA 510(k) clearance K992942. It is classified as a Class II medical device under regulation number 870.4450.

• Which medical specialty is this catheter associated with?

  The device is categorized under the cardiovascular medical specialty, as indicated by its regulatory filing with the cardiovascular advisory committee.