DXZ · Class II · 21 CFR 870.3470

FDA Product Code DXZ: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Leading manufacturers include W.L. Gore & Associates, Inc., Chase Medical, Inc. and Meadox Medicals, Div. Boston Scientific Corp..

90
Total
90
Cleared
137d
Avg days
1977
Since
90 devices
25–48 of 90
Cleared Jan 13, 2005
PFA PATCH
K041736
Peritec Biosciences, LLC
Cardiovascular · 199d
Cleared Jul 22, 2004
PTFE FELTS AND PLEDGETS
K041716
Boston Scientific Corp
Cardiovascular · 28d
Cleared Apr 14, 2004
PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT
K040415
Synovis Surgical Innovations
Cardiovascular · 56d
Cleared Mar 16, 2004
CORRESTORE PATCH SYSTEM
K040162
Somanetics Corp.
Cardiovascular · 50d
Cleared Sep 16, 2003
PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16
K031948
Pm Devices, Inc.
Cardiovascular · 84d
Cleared Aug 07, 2003
CORRESTORE PATCH SYSTEM
K031586
Somanetics Corp.
Cardiovascular · 78d
Cleared Sep 20, 2002
CHASE CARDIOVASCULAR PATCH KIT
K022093
Chase Medical, Inc.
Cardiovascular · 85d
Cleared Jun 03, 2002
CHARE CARIOVASCULAR PATCH
K021129
Chase Medical, Inc.
Cardiovascular · 56d
Cleared Mar 14, 2002
CHASE CARDIOVASCULAR PATCH KIT
K020233
Chase Medical, Inc.
Cardiovascular · 50d
Cleared Feb 26, 2002
CHASE CARDIOVASCULAR PATCH KIT
K020132
Chase Medical, Inc.
Cardiovascular · 42d
Cleared Nov 21, 2001
CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4
K011487
Somanetics Corp.
Cardiovascular · 190d
Cleared Sep 20, 2001
PRECLUDE PERICARDIAL MEMBRANE
K012098
W.L. Gore & Associates, Inc.
Cardiovascular · 77d
Cleared Aug 10, 2001
CHASE CARDIOVASCULAR PATCH
K012248
Chase Medical, Inc.
Cardiovascular · 24d
Cleared Jan 29, 2001
CHASE CARDIOVASCULAR PATCH
K003467
Chase Medical, Inc.
Cardiovascular · 82d
Cleared Dec 27, 2000
SURGISIS PERIPHERAL VASCULAR PATCH
K001785
Cook Biotech, Inc.
Cardiovascular · 197d
Cleared Nov 07, 2000
ETHIBOND EXCEL VALVE LOOP SUTURE
K003070
Ethicon, Inc.
Cardiovascular · 36d
Cleared Aug 02, 2000
CHASE CARDIOVASCULAR PATCH
K001662
Chase Medical, Inc.
Cardiovascular · 63d
Cleared Jul 07, 2000
FLUORO-TEX CARDIOVASCULAR PATCH
K994032
Bridger Biomed, Inc.
Cardiovascular · 224d
Cleared Dec 29, 1999
SULZER CARBOMEDICS CARDIOFIX PERICARDIUM
K993288
Sulzer Carbomedics, Inc.
Cardiovascular · 89d
Cleared Nov 16, 1999
UNI-GRAFT K DV PATCH
K992776
Atrium Medical Corp.
Cardiovascular · 90d
Cleared Apr 08, 1999
ACUSEAL CARDIOVASCULAR PATCH
K984526
W.L. Gore & Associates, Inc.
Cardiovascular · 108d
Cleared Nov 12, 1998
CV PERI-GUARD AND VASCU-GUARD
K983602
Bio-Vascular, Inc.
Cardiovascular · 30d
Cleared Oct 28, 1998
SHELHIGH NO-REACT VASCUPATCH
K982810
Shelhigh, Inc.
Cardiovascular · 78d
Cleared Jun 03, 1998
SHELHIGH NO-REACT PERICARDIAL PATCHES
K974914
Shelhigh, Inc.
Cardiovascular · 177d