Baxter Percutaneous Mechanical Thrombectomy (Pmt) Device, Models PMT0606FD and PMT1206FD

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K993816 ↗

FDA Product Code

MCW

Device Class

Class II

Regulation

21 CFR Part 870.4875

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Baxter Handle Model 1150

  Class I

  FDA 510(k) K944214 Active Cleared 10 Feb 1995

• Baxter Eptfe Externally Supported Vascular Grafts

  Class II

  FDA 510(k) K944858 Active Cleared 5 Jan 1995

• Fogarty Valvulotome Model 700091

  Class II

  FDA 510(k) K965137 Active Cleared 4 Jun 1997

• 4.5F Imagecath Coronary Angioscope, Model COV45

  Class II

  FDA 510(k) K952638 Active Cleared 28 Jul 1995

• Intramed Side Branch Occlusion (Sbo) System (700095 and 700099)

  Class II

  FDA 510(k) K964021 Active Cleared 27 Mar 1997

• Swan-Ganz CC0/SVO2 Thermodilution Catheter

  Class II

  FDA 510(k) K940795 Active Cleared 24 May 1994

See all devices from Baxter Edwards →