Patch, Pledget and Intracardiac, Petp, Ptfe, Polypropylene

• • Terminated Z-2543-2021 FDA Class II ·initiated 8 Jul 2021

  The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

510(k) Number

K972201 ↗

FDA Product Code

DXZ

Device Class

Class II

Regulation

21 CFR Part 870.3470

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Annuloflex Annuloplasty System, Model AF800

  Class II

  FDA 510(k) K992056 Active Cleared 12 Oct 1999

• Sulzer Vascutek Gelsoft Ers Vascular Prosthesis

  Class II

  FDA 510(k) K002007 Active Cleared 25 Jan 2001

• Sulzer Vascutek Gelweave Valsalva Vascular Prosthesis

  Class II

  FDA 510(k) K013022 Active Cleared 13 Jun 2002

• Sulzer Carbomedics Cardiofix Pericardium

  Class II

  FDA 510(k) K993288 Active Cleared 29 Dec 1999

• Annuloflo System, Mitral Model AR700

  Class II

  FDA 510(k) K021051 Active Cleared 23 Apr 2002

• Sulzer Carbomedics Low Profile Mitral Rotator

  Class I

  FDA 510(k) K974648 Active Cleared 4 Aug 1998

See all devices from Sulzer Carbomedics, Inc. →