FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Cardiovascular Prosthetic Devices
CFR Sub-Part
DST
Clip, Vena-Cava
2
Product Code
DSW
Bag, Polymeric Mesh, Pacemaker
1
Product Code
DSY
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
2
Product Code
K
24
1550
Gelweave™ Vascular Prostheses
2
Cleared 510(K)
K
24
1070
Gelsoft™ Plus Vascular Prostheses
2
Cleared 510(K)
K
23
1972
Advanta VXT Vascular Graft, Flixene Vascular Graft
2
Cleared 510(K)
K
24
0083
GORE® PROPATEN® Vascular Graft
2
Cleared 510(K)
K
23
3783
exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts
2
Cleared 510(K)
K
23
2312
GORE® PROPATEN® Vascular Graft
2
Cleared 510(K)
K
23
3551
GORE® ACUSEAL Vascular Graft
2
Cleared 510(K)
K
23
1505
GORE® ACUSEAL Vascular Graft
2
Cleared 510(K)
K
21
3845
HeRO Graft
2
Cleared 510(K)
K
22
1628
exGraft, exGraft Carbon
2
Cleared 510(K)
K
20
3724
HeRO Graft, HeRO Adapter
2
Cleared 510(K)
K
20
2703
Vascutek Gelsoft Plus ERS Vascular Graft
2
Cleared 510(K)
K
20
2471
exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft
2
Cleared 510(K)
K
18
3613
exGraft, exGraft Carbon
2
Cleared 510(K)
K
18
0957
exGraft, exGraft Carbon ePTFE Vascular Grafts
2
Cleared 510(K)
K
17
2637
HeRO Graft
2
Cleared 510(K)
K
16
2803
Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts
2
Cleared 510(K)
K
16
2794
Gelweave Vascular Grafts
2
Cleared 510(K)
K
15
3523
FUSION Vascular Graft
2
Cleared 510(K)
K
15
0389
Spiral Flow Peripheral Vascular Graft
2
Cleared 510(K)
K
14
2062
SPIRAL FLOW PERIPHERAL VASCULAR GRAFT
2
Cleared 510(K)
K
14
1124
SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT
2
Cleared 510(K)
K
13
1778
FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT
2
Cleared 510(K)
K
13
0215
GORE ACUSEAL VASCULAR GRAFT
2
Cleared 510(K)
K
13
0142
FLIXENE IFG VASCULAR GRAFT
2
Cleared 510(K)
K
12
4039
HERO GRAFT
2
Cleared 510(K)
K
13
0016
LIFESPAN EPTFE VASCULAR GRAFT
2
Cleared 510(K)
K
12
2138
ATRIUM FLIXENE IFG VASCULAR GRAFT
2
Cleared 510(K)
K
12
1532
HERO GRAFT
2
Cleared 510(K)
K
12
0006
HERO GRAFT
2
Cleared 510(K)
K
11
3101
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
2
Cleared 510(K)
K
10
3347
CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES
2
Cleared 510(K)
K
10
2596
ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT
2
Cleared 510(K)
K
09
4044
SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT
2
Cleared 510(K)
K
09
3934
GORE HYBRID VASCULAR GRAFT
2
Cleared 510(K)
K
09
3817
GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS
2
Cleared 510(K)
K
09
2863
MAXIFLO, TAPERFLO
2
Cleared 510(K)
K
09
1778
VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS
2
Cleared 510(K)
K
09
1491
HERO VASCULAR ACCESS DEVICE
2
Cleared 510(K)
K
09
0987
VASCUTEK BRANCHED GELWEAVE
2
Cleared 510(K)
K
08
3169
EPTFE SLFTM SPIRAL VASCULAR GRAFT
2
Cleared 510(K)
K
07
1778
HERO VASCULAR ACCESS DEVICE
2
Cleared 510(K)
K
07
1923
PTFE FLIXENE GRADUATED WALL GRAFT
2
Cleared 510(K)
K
06
2161
GORE PROPATEN VASCULAR GRAFT
2
Cleared 510(K)
K
06
1626
VASORING* VRC VASCULAR RING CONNECTOR
2
Cleared 510(K)
K
06
0741
SWIRLGRAFT VASCULAR ACCESS GRAFT
2
Cleared 510(K)
K
06
0124
ATRIUM FLIXENE GRAFT
2
Cleared 510(K)
K
06
0142
VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS
2
Cleared 510(K)
K
05
2964
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
2
Cleared 510(K)
K
05
1312
SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS
2
Cleared 510(K)
K
05
1332
ADVANTA T-GRAFT
2
Cleared 510(K)
K
05
2282
VENAFLO II VASCULAR GRAFT
2
Cleared 510(K)
K
05
0049
DYNAFLO BYPASS GRAFT
2
Cleared 510(K)
K
04
3552
VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES
2
Cleared 510(K)
K
04
1528
MODIFICATION TO EPTFE GRAFT
2
Cleared 510(K)
K
04
0829
GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR
2
Cleared 510(K)
K
03
4010
GELSOFT PLUS ERS
2
Cleared 510(K)
K
03
2900
LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS
2
Cleared 510(K)
K
03
0999
EPTFE VASCULAR PROSTHESIS; SEALPTFE
2
Cleared 510(K)
K
02
1547
FLOWLINE BIOPORE EPTFE VASCULAR GRAFT
2
Cleared 510(K)
K
02
2242
INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER
2
Cleared 510(K)
K
01
3022
SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS
2
Cleared 510(K)
K
02
0767
ADVANTA SST BIFURCATED GRAFT
2
Cleared 510(K)
K
01
3651
INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS
2
Cleared 510(K)
K
01
3577
ULTRAMAX WOVEN VELOUR VASCULAR GRAFT
2
Cleared 510(K)
K
01
3250
GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT
2
Cleared 510(K)
K
01
2952
HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT
2
Cleared 510(K)
K
01
0517
ADVANTA SST GRAFT (<6MM)
2
Cleared 510(K)
K
01
0516
ADVANTA SST GRAFT (>_6MM)
2
Cleared 510(K)
K
00
4011
IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS
2
Cleared 510(K)
K
00
2007
SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS
2
Cleared 510(K)
K
99
0800
INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS
2
Cleared 510(K)
K
00
1927
VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME
2
Cleared 510(K)
K
00
0499
ADVANTA SUPER SOFT GRAFT
2
Cleared 510(K)
K
99
3667
SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS
2
Cleared 510(K)
K
99
0503
SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS
2
Cleared 510(K)
K
99
2832
SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS
2
Cleared 510(K)
K
99
2960
ADVANTA GRAFT (>6MM)
2
Cleared 510(K)
K
99
2443
ADVANTA GRAFT
2
Cleared 510(K)
K
99
1602
EPTFE RINGED GORE-TEX VASCULAR GRAFT
2
Cleared 510(K)
K
99
1813
UNI-GRAFT K DV VASCULAR GRAFT
2
Cleared 510(K)
K
99
1027
BI-DIRECTIONAL TUNNELER
2
Cleared 510(K)
K
98
4294
MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
2
Cleared 510(K)
K
98
4182
PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452
2
Cleared 510(K)
K
98
3861
DISTAFLO BYPASS GRAFT
2
Cleared 510(K)
K
98
3819
INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN
2
Cleared 510(K)
K
98
3064
IMPRA HIGH POROSITY GRAFT
2
Cleared 510(K)
K
98
1079
VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
2
Cleared 510(K)
K
96
3790
UNI-GRAFT K DV
2
Cleared 510(K)
K
97
0843
INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
2
Cleared 510(K)
K
96
4625
HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES
2
Cleared 510(K)
K
97
1192
IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT
2
Cleared 510(K)
K
96
2433
MEADOX EXXCEL EPTFE VASCULAR GRAFT
2
Cleared 510(K)
K
96
4959
VASCUTEK TWILLWEAVE VASCULAR GRAFT
2
Cleared 510(K)
K
96
4665
VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)
2
Cleared 510(K)
K
96
1847
HEMASHIELD VANTAGE (VASCULAR GRAFT
2
Cleared 510(K)
K
96
4197
IMPRA CARBOFLO EPTFE VASCULAR GRAFT
2
Cleared 510(K)
K
96
2639
IMPRA CARBOFLO EPTFE VASCULAR GRAFT
2
Cleared 510(K)
K
96
1134
BARD GRAFT SIZER
2
Cleared 510(K)
K
95
5460
MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT
2
Cleared 510(K)
K
96
0706
VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT
2
Cleared 510(K)
K
95
5532
DIASTAT VASCULAR ACCESS GRAFT
2
Cleared 510(K)
K
95
5588
VASCUTEK GRAFT SIZER SET
2
Cleared 510(K)
K
95
5230
VASCUTEK GELSOFT PLUS VASCULAR GRAFT
2
Cleared 510(K)
K
95
2293
VASCUTEK GELWEAVE VASCULAR GRAFT
2
Cleared 510(K)
K
95
4582
BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)
2
Cleared 510(K)
K
95
3288
DIASTAT VASCULAR ACCESS GRAFT
2
Cleared 510(K)
K
94
4858
BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS
2
Cleared 510(K)
K
94
1981
AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED
2
Cleared 510(K)
K
94
0816
BARD(R) EXPANDED PTFE VASCULAR GRAFT
2
Cleared 510(K)
K
93
3987
AOR-TEX VASCULAR GRAFT
2
Cleared 510(K)
K
94
0062
DIASTAT VASCULAR ACCESS GRAFT
2
Cleared 510(K)
K
93
3590
BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT
2
Cleared 510(K)
K
93
3943
FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS
2
Cleared 510(K)
K
93
3204
BARD PTFE VASCULAR GRAFT
2
Cleared 510(K)
K
92
5123
ATRIUM'S HYBRID PTFE
2
Cleared 510(K)
P
84
0029
HEMASHIELD(R) MICROVEL (R) DOUBLE VELOUR GRAFT
2
PMA Approval
P
84
0029
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 7MMX100CM
2
PMA Approval
P
84
0029
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 12 X 6MM
2
PMA Approval
P
84
0029
HEMASHIELD ETS(TM) FLANGED GRAFT
2
PMA Approval
P
84
0029
HEMASHIELD(R) WOVEN DOUBLE VELOUR GRAFT
2
PMA Approval
P
84
0029
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS
2
PMA Approval
P
84
0029
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS
2
PMA Approval
P
84
0029
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 7MMX100CM
2
PMA Approval
P
84
0029
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS
2
PMA Approval
K
92
2905
FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT
2
Cleared 510(K)
K
92
2025
ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF
2
Cleared 510(K)
K
91
4116
PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION
2
Cleared 510(K)
K
91
4447
GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE
2
Cleared 510(K)
K
91
3143
OCHSNER ULP BIFURCATION VASCULAR PROTHESIS
2
Cleared 510(K)
K
91
2911
LOW POROSITY (LP) VASCULAR PROSTHESIS
2
Cleared 510(K)
K
90
5269
OCHSNER 500 VASCULAR PROSTHESIS
2
Cleared 510(K)
K
91
0866
VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS
2
Cleared 510(K)
K
91
0863
EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS
2
Cleared 510(K)
K
91
0864
EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS
2
Cleared 510(K)
K
91
0865
TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS
2
Cleared 510(K)
K
90
5067
PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT
2
Cleared 510(K)
K
90
5270
OCHSNER 50 VASCULAR PROSTHESIS
2
Cleared 510(K)
K
90
4282
BIFURCATED GORE TEX STRETCH VASCULAR GRAFT
2
Cleared 510(K)
K
90
3931
GORE-TEX(R) STRETCH VASCULAR GRAFT
2
Cleared 510(K)
K
90
3964
OCHSNER 50 BIFURCATION
2
Cleared 510(K)
K
90
1641
AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT
2
Cleared 510(K)
P
84
0029
MICROVEL(R) WITH HEMASHIELD
2
PMA Approval
K
90
1682
PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS
2
Cleared 510(K)
K
89
6964
PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC.
2
Cleared 510(K)
K
89
0182
PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV
2
Cleared 510(K)
K
89
4732
VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION)
2
Cleared 510(K)
K
89
0597
EXTENDED PACKAGE DATING ON VELEX WOVEN GRAFTS
2
Cleared 510(K)
K
89
3459
PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE)
2
Cleared 510(K)
P
84
0029
MICROVEL(R) WITH HEMASHIELD
2
PMA Approval
K
88
4083
TORAY VASCULAR PROSTHESIS
2
Cleared 510(K)
K
88
2289
ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.
2
Cleared 510(K)
K
88
2314
CORONARY VEIN GRAFT MARKER
2
Cleared 510(K)
K
88
0041
VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT
2
Cleared 510(K)
K
88
0040
VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT
2
Cleared 510(K)
K
88
1283
MEADOX INTRA-AORTIC GRAFT
2
Cleared 510(K)
K
88
0167
GORE-TEX VASCULAR GRAFT
2
Cleared 510(K)
K
87
0884
RADIALLY-SUPPORTED VASCULAR PROSTHESES
2
Cleared 510(K)
K
87
1110
CORONARY ARTERY BYPASS GRAFT (CABG) MARKER
2
Cleared 510(K)
K
86
2697
AVTECH LWP*(LOW POROSITY) MWP*(MEDIUM POROSITY)
2
Cleared 510(K)
K
86
1808
VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN
2
Cleared 510(K)
K
86
2739
INTERVASCULAR OCHSNER MICRON VASCULAR PROSTHESES
2
Cleared 510(K)
K
85
4845
INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR
2
Cleared 510(K)
K
84
1596
MEADOS INTRAORTIC GRAFT
2
Cleared 510(K)
K
85
4431
MEADOX MEDICALS INC. GRAFT SIZER
2
Cleared 510(K)
K
85
3101
VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES
2
Cleared 510(K)
K
85
3725
ATRIUM PLASMA TFE SYNTHETIC ARTERY
2
Cleared 510(K)
K
83
1822
TETRAFLEX INTEGRALLY SUPPORTED PTFE
2
Cleared 510(K)
K
83
3716
LP200 & HP800 SERIES VASCULAR PROSTH
2
Cleared 510(K)
K
83
0016
VASCUTEK VASCULAR PROTHESIS VP1200K/50K
2
Cleared 510(K)
K
83
1880
IONESCU-SHILEY LOW POROSITY AORTIC GRAFT
2
Cleared 510(K)
K
83
1865
IONESCU-SHILEY LOW POROSITY COMPOSITE
2
Cleared 510(K)
K
83
2806
CORONARY ANASTOMOSIS MARKING SYSTEM
2
Cleared 510(K)
K
83
0543
VASCULAR GRAFT PROSTHESIS EXPANDED MICR
2
Cleared 510(K)
K
82
2633
MICROVEL DOUBLE VELOUR SUPPORTED 100
2
Cleared 510(K)
K
82
1716
BARD PTFE VASCULAR PROSTHESIS
2
Cleared 510(K)
K
82
0696
MEADOX WOVEN DOUBLE VELOUR
2
Cleared 510(K)
K
82
0600
HANCOCK VASCULAR GRAFT
2
Cleared 510(K)
K
82
1158
FED RINGED-TEX VASCULAR GRAFT
2
Cleared 510(K)
K
81
2248
COOLEY 2 VASCULAR PROSTHESIS STRAIGHT
2
Cleared 510(K)
K
81
1441
MANUFACTURING PROCESS CHANGE
2
Cleared 510(K)
K
81
1510
GORE-TEX VASULAR GRAFT
2
Cleared 510(K)
K
81
0845
DOUBLE VELOUR GRAFTS
2
Cleared 510(K)
K
81
0376
MEADOX SZILAGYI GRAFT
2
Cleared 510(K)
K
80
3000
IONESCU-SHILEY AORTIC GRAFT VALVE
2
Cleared 510(K)
K
80
2095
GORE-TEX VASCULAR GRAFT
2
Cleared 510(K)
K
80
1621
VASCULAR GRAFT PROSTH. OF EXP. MICRO.
2
Cleared 510(K)
K
80
1156
USCI INTRALUMINAL GRAFT W/DACRON TIE
2
Cleared 510(K)
K
80
0149
USCI SAUVAGE EXS VASCULAR PROSTHESIS
2
Cleared 510(K)
K
79
1828
BJORK-SHILEY PULMONIC GRAFT VALVE
2
Cleared 510(K)
K
77
1819
CABG RINGS
2
Cleared 510(K)
K
77
0236
SAUVAGE FILAMENTOUS PROSTHESES
2
Cleared 510(K)
K
77
0235
DEBAKEY VASCULOUR-D PROSTHESES
2
Cleared 510(K)
K
76
0130
PROSTHESIS, VASCULAR BIFURCATED
2
Cleared 510(K)
K
76
0091
GRAFT, MICROVEL GUIDELINE, STERILE
2
Cleared 510(K)
K
76
0092
GRAFT, COOLEY WOVEN VASCULAR, STERILE
2
Cleared 510(K)
K
76
0090
GRAFT, COOLEY GUIDELINE, STERILE
2
Cleared 510(K)
DSZ
Pacemaker Battery
3
Product Code
DTA
Tester, Pacemaker Electrode Function
2
Product Code
DTB
Permanent Pacemaker Electrode
3
Product Code
DTC
Analyzer, Pacemaker Generator Function
2
Product Code
DTD
Pacemaker Lead Adaptor
2
Product Code
DTE
Pulse-Generator, Pacemaker, External
2
Product Code
DTF
Tools, Pacemaker Service
1
Product Code
DTG
Magnet, Test, Pacemaker
1
Product Code
DTI
Sizer, Heart-Valve, Prosthesis
1
Product Code
DTJ
Holder, Heart-Valve, Prosthesis
1
Product Code
DTK
Filter, Intravascular, Cardiovascular
2
Product Code
DSP
System, Balloon, Intra-Aortic And Control
2
Product Code
DSR
Stimulator, Carotid Sinus Nerve
3
Product Code
DSS
Clip, Vascular
2
Product Code
DXY
Implantable Pacemaker Pulse-Generator
3
Product Code
DXZ
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
2
Product Code
DYE
Replacement Heart-Valve
3
Product Code
DYF
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
2
Product Code
KFJ
Materials, Repair Or Replacement, Pacemaker
3
Product Code
KRD
Device, Vascular, For Promoting Embolization
2
Product Code
KRE
Analyzer, Pacemaker Generator Function, Indirect
2
Product Code
KRF
Charger, Pacemaker
1
Product Code
KRG
Programmer, Pacemaker
3
Product Code
KRH
Ring, Annuloplasty
2
Product Code
LDF
Electrode, Pacemaker, Temporary
2
Product Code
MAB
Marker, Cardiopulmonary Bypass (Vein Marker)
2
Product Code
MAL
Graft, Vascular, Synthetic/Biologic Composite
2
Product Code
MFX
Vessel Guard Or Cover, To Facilitate Revision Surgeries
2
Product Code
MOP
Rotator, Prosthetic Heart Valve
1
Product Code
MZY
Graft, Vascular, Stainless Steel Tunneler
2
Product Code
NHW
Electrode, Pacing And Cardioversion, Temporary, Epicardial
2
Product Code
NKO
System, Balloon, Intra-Aortic And Control, Reprocessed
3
Product Code
OKR
Ventricular Bypass (Assist) Device
3
Product Code
OMH
Pericardial Patch To Facilitate Revision Surgeries
2
Product Code
OMR
Vessel Guard Or Cover
2
Product Code
OTD
Endovascular Suturing System
2
Product Code
OVJ
Pulse Generator, External Pacemaker, Dual Chamber
2
Product Code
PAL
Pulmonic Replacement Heart Valve
F
Product Code
PCK
Pediatric Ventricular Assist Device
F
Product Code
PNJ
Leadless Pacemaker
3
Product Code
PNS
Short-Term Intravascular Filter Catheter
2
Product Code
PSQ
Intracardiac Patch Or Pledget, Biologically Derived
2
Product Code
PST
Aortic Annuloplasty Ring
2
Product Code
QAB
Pacing System Analyzer
2
Product Code
Subpart E—Cardiovascular Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 May 2025 at 11:05 pm
CV
/
subpart-d—cardiovascular-prosthetic-devices
/
DSY
/
K771819
View Source
CABG RINGS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K771819
510(k) Type
Traditional
Applicant
A&A ENT.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/21/1977
Days to Decision
25 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Cardiovascular Prosthetic Devices
DST
Clip, Vena-Cava
DSW
Bag, Polymeric Mesh, Pacemaker
DSY
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
K
24
1550
Gelweave™ Vascular Prostheses
K
24
1070
Gelsoft™ Plus Vascular Prostheses
K
23
1972
Advanta VXT Vascular Graft, Flixene Vascular Graft
K
24
0083
GORE® PROPATEN® Vascular Graft
K
23
3783
exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts
K
23
2312
GORE® PROPATEN® Vascular Graft
K
23
3551
GORE® ACUSEAL Vascular Graft
K
23
1505
GORE® ACUSEAL Vascular Graft
K
21
3845
HeRO Graft
K
22
1628
exGraft, exGraft Carbon
K
20
3724
HeRO Graft, HeRO Adapter
K
20
2703
Vascutek Gelsoft Plus ERS Vascular Graft
K
20
2471
exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft
K
18
3613
exGraft, exGraft Carbon
K
18
0957
exGraft, exGraft Carbon ePTFE Vascular Grafts
K
17
2637
HeRO Graft
K
16
2803
Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts
K
16
2794
Gelweave Vascular Grafts
K
15
3523
FUSION Vascular Graft
K
15
0389
Spiral Flow Peripheral Vascular Graft
K
14
2062
SPIRAL FLOW PERIPHERAL VASCULAR GRAFT
K
14
1124
SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT
K
13
1778
FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT
K
13
0215
GORE ACUSEAL VASCULAR GRAFT
K
13
0142
FLIXENE IFG VASCULAR GRAFT
K
12
4039
HERO GRAFT
K
13
0016
LIFESPAN EPTFE VASCULAR GRAFT
K
12
2138
ATRIUM FLIXENE IFG VASCULAR GRAFT
K
12
1532
HERO GRAFT
K
12
0006
HERO GRAFT
K
11
3101
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
K
10
3347
CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES
K
10
2596
ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT
K
09
4044
SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT
K
09
3934
GORE HYBRID VASCULAR GRAFT
K
09
3817
GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS
K
09
2863
MAXIFLO, TAPERFLO
K
09
1778
VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS
K
09
1491
HERO VASCULAR ACCESS DEVICE
K
09
0987
VASCUTEK BRANCHED GELWEAVE
K
08
3169
EPTFE SLFTM SPIRAL VASCULAR GRAFT
K
07
1778
HERO VASCULAR ACCESS DEVICE
K
07
1923
PTFE FLIXENE GRADUATED WALL GRAFT
K
06
2161
GORE PROPATEN VASCULAR GRAFT
K
06
1626
VASORING* VRC VASCULAR RING CONNECTOR
K
06
0741
SWIRLGRAFT VASCULAR ACCESS GRAFT
K
06
0124
ATRIUM FLIXENE GRAFT
K
06
0142
VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS
K
05
2964
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
K
05
1312
SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS
K
05
1332
ADVANTA T-GRAFT
K
05
2282
VENAFLO II VASCULAR GRAFT
K
05
0049
DYNAFLO BYPASS GRAFT
K
04
3552
VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES
K
04
1528
MODIFICATION TO EPTFE GRAFT
K
04
0829
GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR
K
03
4010
GELSOFT PLUS ERS
K
03
2900
LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS
K
03
0999
EPTFE VASCULAR PROSTHESIS; SEALPTFE
K
02
1547
FLOWLINE BIOPORE EPTFE VASCULAR GRAFT
K
02
2242
INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER
K
01
3022
SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS
K
02
0767
ADVANTA SST BIFURCATED GRAFT
K
01
3651
INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS
K
01
3577
ULTRAMAX WOVEN VELOUR VASCULAR GRAFT
K
01
3250
GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT
K
01
2952
HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT
K
01
0517
ADVANTA SST GRAFT (<6MM)
K
01
0516
ADVANTA SST GRAFT (>_6MM)
K
00
4011
IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS
K
00
2007
SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS
K
99
0800
INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS
K
00
1927
VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME
K
00
0499
ADVANTA SUPER SOFT GRAFT
K
99
3667
SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS
K
99
0503
SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS
K
99
2832
SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS
K
99
2960
ADVANTA GRAFT (>6MM)
K
99
2443
ADVANTA GRAFT
K
99
1602
EPTFE RINGED GORE-TEX VASCULAR GRAFT
K
99
1813
UNI-GRAFT K DV VASCULAR GRAFT
K
99
1027
BI-DIRECTIONAL TUNNELER
K
98
4294
MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
K
98
4182
PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452
K
98
3861
DISTAFLO BYPASS GRAFT
K
98
3819
INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN
K
98
3064
IMPRA HIGH POROSITY GRAFT
K
98
1079
VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
K
96
3790
UNI-GRAFT K DV
K
97
0843
INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
K
96
4625
HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES
K
97
1192
IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT
K
96
2433
MEADOX EXXCEL EPTFE VASCULAR GRAFT
K
96
4959
VASCUTEK TWILLWEAVE VASCULAR GRAFT
K
96
4665
VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)
K
96
1847
HEMASHIELD VANTAGE (VASCULAR GRAFT
K
96
4197
IMPRA CARBOFLO EPTFE VASCULAR GRAFT
K
96
2639
IMPRA CARBOFLO EPTFE VASCULAR GRAFT
K
96
1134
BARD GRAFT SIZER
K
95
5460
MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT
K
96
0706
VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT
K
95
5532
DIASTAT VASCULAR ACCESS GRAFT
K
95
5588
VASCUTEK GRAFT SIZER SET
K
95
5230
VASCUTEK GELSOFT PLUS VASCULAR GRAFT
K
95
2293
VASCUTEK GELWEAVE VASCULAR GRAFT
K
95
4582
BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)
K
95
3288
DIASTAT VASCULAR ACCESS GRAFT
K
94
4858
BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS
K
94
1981
AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED
K
94
0816
BARD(R) EXPANDED PTFE VASCULAR GRAFT
K
93
3987
AOR-TEX VASCULAR GRAFT
K
94
0062
DIASTAT VASCULAR ACCESS GRAFT
K
93
3590
BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT
K
93
3943
FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS
K
93
3204
BARD PTFE VASCULAR GRAFT
K
92
5123
ATRIUM'S HYBRID PTFE
P
84
0029
HEMASHIELD(R) MICROVEL (R) DOUBLE VELOUR GRAFT
P
84
0029
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 7MMX100CM
P
84
0029
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 12 X 6MM
P
84
0029
HEMASHIELD ETS(TM) FLANGED GRAFT
P
84
0029
HEMASHIELD(R) WOVEN DOUBLE VELOUR GRAFT
P
84
0029
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS
P
84
0029
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS
P
84
0029
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 7MMX100CM
P
84
0029
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS
K
92
2905
FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT
K
92
2025
ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF
K
91
4116
PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION
K
91
4447
GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE
K
91
3143
OCHSNER ULP BIFURCATION VASCULAR PROTHESIS
K
91
2911
LOW POROSITY (LP) VASCULAR PROSTHESIS
K
90
5269
OCHSNER 500 VASCULAR PROSTHESIS
K
91
0866
VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS
K
91
0863
EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS
K
91
0864
EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS
K
91
0865
TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS
K
90
5067
PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT
K
90
5270
OCHSNER 50 VASCULAR PROSTHESIS
K
90
4282
BIFURCATED GORE TEX STRETCH VASCULAR GRAFT
K
90
3931
GORE-TEX(R) STRETCH VASCULAR GRAFT
K
90
3964
OCHSNER 50 BIFURCATION
K
90
1641
AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT
P
84
0029
MICROVEL(R) WITH HEMASHIELD
K
90
1682
PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS
K
89
6964
PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC.
K
89
0182
PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV
K
89
4732
VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION)
K
89
0597
EXTENDED PACKAGE DATING ON VELEX WOVEN GRAFTS
K
89
3459
PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE)
P
84
0029
MICROVEL(R) WITH HEMASHIELD
K
88
4083
TORAY VASCULAR PROSTHESIS
K
88
2289
ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.
K
88
2314
CORONARY VEIN GRAFT MARKER
K
88
0041
VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT
K
88
0040
VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT
K
88
1283
MEADOX INTRA-AORTIC GRAFT
K
88
0167
GORE-TEX VASCULAR GRAFT
K
87
0884
RADIALLY-SUPPORTED VASCULAR PROSTHESES
K
87
1110
CORONARY ARTERY BYPASS GRAFT (CABG) MARKER
K
86
2697
AVTECH LWP*(LOW POROSITY) MWP*(MEDIUM POROSITY)
K
86
1808
VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN
K
86
2739
INTERVASCULAR OCHSNER MICRON VASCULAR PROSTHESES
K
85
4845
INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR
K
84
1596
MEADOS INTRAORTIC GRAFT
K
85
4431
MEADOX MEDICALS INC. GRAFT SIZER
K
85
3101
VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES
K
85
3725
ATRIUM PLASMA TFE SYNTHETIC ARTERY
K
83
1822
TETRAFLEX INTEGRALLY SUPPORTED PTFE
K
83
3716
LP200 & HP800 SERIES VASCULAR PROSTH
K
83
0016
VASCUTEK VASCULAR PROTHESIS VP1200K/50K
K
83
1880
IONESCU-SHILEY LOW POROSITY AORTIC GRAFT
K
83
1865
IONESCU-SHILEY LOW POROSITY COMPOSITE
K
83
2806
CORONARY ANASTOMOSIS MARKING SYSTEM
K
83
0543
VASCULAR GRAFT PROSTHESIS EXPANDED MICR
K
82
2633
MICROVEL DOUBLE VELOUR SUPPORTED 100
K
82
1716
BARD PTFE VASCULAR PROSTHESIS
K
82
0696
MEADOX WOVEN DOUBLE VELOUR
K
82
0600
HANCOCK VASCULAR GRAFT
K
82
1158
FED RINGED-TEX VASCULAR GRAFT
K
81
2248
COOLEY 2 VASCULAR PROSTHESIS STRAIGHT
K
81
1441
MANUFACTURING PROCESS CHANGE
K
81
1510
GORE-TEX VASULAR GRAFT
K
81
0845
DOUBLE VELOUR GRAFTS
K
81
0376
MEADOX SZILAGYI GRAFT
K
80
3000
IONESCU-SHILEY AORTIC GRAFT VALVE
K
80
2095
GORE-TEX VASCULAR GRAFT
K
80
1621
VASCULAR GRAFT PROSTH. OF EXP. MICRO.
K
80
1156
USCI INTRALUMINAL GRAFT W/DACRON TIE
K
80
0149
USCI SAUVAGE EXS VASCULAR PROSTHESIS
K
79
1828
BJORK-SHILEY PULMONIC GRAFT VALVE
K
77
1819
CABG RINGS
K
77
0236
SAUVAGE FILAMENTOUS PROSTHESES
K
77
0235
DEBAKEY VASCULOUR-D PROSTHESES
K
76
0130
PROSTHESIS, VASCULAR BIFURCATED
K
76
0091
GRAFT, MICROVEL GUIDELINE, STERILE
K
76
0092
GRAFT, COOLEY WOVEN VASCULAR, STERILE
K
76
0090
GRAFT, COOLEY GUIDELINE, STERILE
DSZ
Pacemaker Battery
DTA
Tester, Pacemaker Electrode Function
DTB
Permanent Pacemaker Electrode
DTC
Analyzer, Pacemaker Generator Function
DTD
Pacemaker Lead Adaptor
DTE
Pulse-Generator, Pacemaker, External
DTF
Tools, Pacemaker Service
DTG
Magnet, Test, Pacemaker
DTI
Sizer, Heart-Valve, Prosthesis
DTJ
Holder, Heart-Valve, Prosthesis
DTK
Filter, Intravascular, Cardiovascular
DSP
System, Balloon, Intra-Aortic And Control
DSR
Stimulator, Carotid Sinus Nerve
DSS
Clip, Vascular
DXY
Implantable Pacemaker Pulse-Generator
DXZ
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
DYE
Replacement Heart-Valve
DYF
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
KFJ
Materials, Repair Or Replacement, Pacemaker
KRD
Device, Vascular, For Promoting Embolization
KRE
Analyzer, Pacemaker Generator Function, Indirect
KRF
Charger, Pacemaker
KRG
Programmer, Pacemaker
KRH
Ring, Annuloplasty
LDF
Electrode, Pacemaker, Temporary
MAB
Marker, Cardiopulmonary Bypass (Vein Marker)
MAL
Graft, Vascular, Synthetic/Biologic Composite
MFX
Vessel Guard Or Cover, To Facilitate Revision Surgeries
MOP
Rotator, Prosthetic Heart Valve
MZY
Graft, Vascular, Stainless Steel Tunneler
NHW
Electrode, Pacing And Cardioversion, Temporary, Epicardial
NKO
System, Balloon, Intra-Aortic And Control, Reprocessed
OKR
Ventricular Bypass (Assist) Device
OMH
Pericardial Patch To Facilitate Revision Surgeries
OMR
Vessel Guard Or Cover
OTD
Endovascular Suturing System
OVJ
Pulse Generator, External Pacemaker, Dual Chamber
PAL
Pulmonic Replacement Heart Valve
PCK
Pediatric Ventricular Assist Device
PNJ
Leadless Pacemaker
PNS
Short-Term Intravascular Filter Catheter
PSQ
Intracardiac Patch Or Pledget, Biologically Derived
PST
Aortic Annuloplasty Ring
QAB
Pacing System Analyzer
Subpart E—Cardiovascular Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Therapeutic Devices
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
CV
/
subpart-d—cardiovascular-prosthetic-devices
/
DSY
/
K771819
View Source
CABG RINGS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K771819
510(k) Type
Traditional
Applicant
A&A ENT.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/21/1977
Days to Decision
25 days