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
Subpart E—Cardiovascular Surgical Devices
CFR Sub-Part
BYS
Oxygenator, Long Term Support Greater Than 6 Hours
2
Product Code
DRY
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
2
Product Code
DTL
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
2
Product Code
DTM
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
2
Product Code
DTN
Reservoir, Blood, Cardiopulmonary Bypass
2
Product Code
K
24
1206
Quantum Perfusion Hybrid System
2
Cleared 510(K)
K
24
1053
MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL
2
Cleared 510(K)
K
22
3361
BMR 1900 PHISIO
2
Cleared 510(K)
K
17
0583
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
2
Cleared 510(K)
K
16
1733
INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
2
Cleared 510(K)
K
15
3143
Capiox Advance Hardshell Reservoir
2
Cleared 510(K)
K
15
1110
Intersept Filtered Cardiotomy Reservoir
2
Cleared 510(K)
K
14
1432
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
2
Cleared 510(K)
K
14
1233
AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE
2
Cleared 510(K)
K
14
0321
INITARY BETTER BLADDER-PEDIATRIC
2
Cleared 510(K)
K
13
2166
VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
2
Cleared 510(K)
K
13
2972
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
2
Cleared 510(K)
K
13
1103
XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
2
Cleared 510(K)
K
12
2914
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE
2
Cleared 510(K)
K
11
2771
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
2
Cleared 510(K)
K
10
2919
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE
2
Cleared 510(K)
K
10
0507
XRES BLOOD COLLECTION RESERVOIR
2
Cleared 510(K)
K
09
0690
VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
2
Cleared 510(K)
K
09
0534
VENOUS HARDSHELL CARDIOTOMY RESERVIORS
2
Cleared 510(K)
K
09
2315
SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
2
Cleared 510(K)
K
09
1062
MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
2
Cleared 510(K)
K
08
3131
MEDOS HILITE RESERVOIR, MODEL: 4030
2
Cleared 510(K)
K
08
2082
GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
2
Cleared 510(K)
K
08
1947
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
2
Cleared 510(K)
K
07
0605
JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING
2
Cleared 510(K)
K
07
2697
3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES
2
Cleared 510(K)
K
07
0839
MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR
2
Cleared 510(K)
K
06
1743
VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001
2
Cleared 510(K)
K
06
1527
CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
2
Cleared 510(K)
K
05
1606
GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING
2
Cleared 510(K)
K
05
0195
V-BAG WITH GBS COATING
2
Cleared 510(K)
K
05
0111
SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG
2
Cleared 510(K)
K
04
0023
CAPIOX FLEXIBLE VENOUS RESERVOIR
2
Cleared 510(K)
K
03
3800
CAPIOX CARDIOTOMY RESERVOIR
2
Cleared 510(K)
K
03
3714
MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING
2
Cleared 510(K)
K
03
3641
SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
2
Cleared 510(K)
K
03
1700
MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
2
Cleared 510(K)
K
03
1150
HEMOBAG, MODEL HBBSD2000
2
Cleared 510(K)
K
03
0726
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING
2
Cleared 510(K)
K
03
0449
MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
2
Cleared 510(K)
K
02
4065
SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING
2
Cleared 510(K)
K
02
2281
SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
2
Cleared 510(K)
K
02
1287
TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT
2
Cleared 510(K)
K
01
3526
CAPIOX RX HARDSHELL RESERVOIR
2
Cleared 510(K)
K
01
2942
THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500
2
Cleared 510(K)
K
00
3551
VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201
2
Cleared 510(K)
K
01
1864
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
2
Cleared 510(K)
K
00
2496
MODEL 4815 ADAPTER
2
Cleared 510(K)
K
00
2238
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
2
Cleared 510(K)
K
00
1822
THE V-BAG
2
Cleared 510(K)
K
00
1602
DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.)
2
Cleared 510(K)
K
99
4389
COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED
2
Cleared 510(K)
K
99
3001
COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED
2
Cleared 510(K)
K
99
2599
DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR
2
Cleared 510(K)
K
99
1973
CAPIOX SX10 HARDSHELL RESEVOIR
2
Cleared 510(K)
K
98
4586
FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS
2
Cleared 510(K)
K
99
0239
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
2
Cleared 510(K)
K
98
2136
JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200
2
Cleared 510(K)
K
98
4456
COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
2
Cleared 510(K)
K
98
2223
CAPIOX SX HARDSHELL RESEVOIR
2
Cleared 510(K)
K
98
0786
COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800
2
Cleared 510(K)
K
98
1284
BETTER-BLADDER (BB)
2
Cleared 510(K)
K
98
1628
BARD QUANTUM SVR MODEL NUMBER H-6440VR
2
Cleared 510(K)
K
98
0935
CAPIOX SX HARDSHELL RESERVOIR
2
Cleared 510(K)
K
97
4155
BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT
2
Cleared 510(K)
K
97
1013
CHASE TEMPERATURE PROBE
2
Cleared 510(K)
K
97
2017
BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)
2
Cleared 510(K)
K
96
4908
VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER
2
Cleared 510(K)
K
96
4907
VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT
2
Cleared 510(K)
K
97
1669
COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR
2
Cleared 510(K)
K
97
1105
MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM
2
Cleared 510(K)
K
96
4973
GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR
2
Cleared 510(K)
K
96
1836
MAXIMA FORTE HARDSHELL VENOUS RESERVOIR
2
Cleared 510(K)
K
95
3821
BIOCOR 200 HARDSHELL VENOUS RESERVIOR
2
Cleared 510(K)
K
95
5046
SOFT VENOUS RESERVOIR
2
Cleared 510(K)
K
94
5065
DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063
2
Cleared 510(K)
K
94
1215
VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR
2
Cleared 510(K)
K
93
6003
AFFINITY CVR
2
Cleared 510(K)
K
93
5717
AFFINITY VENOUS RESERVIOR BAG
2
Cleared 510(K)
K
93
4847
NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS
2
Cleared 510(K)
K
93
4763
SORIN BLOOD CARDIOPLEGIA SYSTEM
2
Cleared 510(K)
K
93
6183
SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS
2
Cleared 510(K)
K
93
3713
VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT
2
Cleared 510(K)
K
93
6286
ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)
2
Cleared 510(K)
K
93
3481
SORIN MONOLYTH VENOUS RESERVOIR
2
Cleared 510(K)
K
93
0154
EL2-SERIES BLOOD COLLECTION REERVOIR
2
Cleared 510(K)
K
93
0299
BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET
2
Cleared 510(K)
K
92
0178
CARDIOTOMY RESERVOIR W/20 MICRON FILITER
2
Cleared 510(K)
K
92
5046
PLEUR-EVAC CARDIOTOMY RESERVOIR
2
Cleared 510(K)
K
92
6250
ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR
2
Cleared 510(K)
K
91
5573
VENOUS RESERVOIR W/CARDIOTOMY FILTER
2
Cleared 510(K)
K
92
0774
MVR COLLAPSIBLE VENOUS RESERVOIR BAG
2
Cleared 510(K)
K
92
0312
NEW COBE CARDIOPLEGIA SYSTEM
2
Cleared 510(K)
K
91
5737
AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR
2
Cleared 510(K)
K
91
3915
BARD(R) WILLIAM HARVEY(R) MACRO FILT CARDIO RESERV
2
Cleared 510(K)
K
91
3956
BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30
2
Cleared 510(K)
K
91
3692
VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)
2
Cleared 510(K)
K
91
1790
MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG
2
Cleared 510(K)
K
91
1876
SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200
2
Cleared 510(K)
K
90
5818
VACUUM-ASSISTED BLOOD COLLECTION SYSTEM
2
Cleared 510(K)
K
90
3632
INTERSEPT 1375 VENOUS RESERVOIR
2
Cleared 510(K)
K
90
2631
COBE ICU CONVERSION KIT
2
Cleared 510(K)
K
90
4040
SOFTSHELL VENOUS RESERVOIR
2
Cleared 510(K)
K
89
4664
CAPIOX HARDSHELL VENOUS RESERVOIR
2
Cleared 510(K)
K
89
5356
UNIVOX-IC
2
Cleared 510(K)
K
89
3711
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
2
Cleared 510(K)
K
89
6414
VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN
2
Cleared 510(K)
K
89
3705
SAFE-1 VENOUS RESERVOIR
2
Cleared 510(K)
K
89
5076
CMS VRB-1200
2
Cleared 510(K)
K
89
0077
TRAUMAFUSE RAPID INFUSION DEVICE
2
Cleared 510(K)
K
88
4872
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
2
Cleared 510(K)
K
88
2414
BLOOD RESERVOIR, CARDIOPULMONARY BYPASS
2
Cleared 510(K)
K
88
3923
CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES
2
Cleared 510(K)
K
88
2380
SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR
2
Cleared 510(K)
K
88
3345
SARNS INFANT VENOUS RESERVOIR MODEL #16387
2
Cleared 510(K)
K
88
2720
SCIMED R30 SILICONE ASSIST RESERVOIR
2
Cleared 510(K)
K
87
3423
MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER
2
Cleared 510(K)
K
87
2719
EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER
2
Cleared 510(K)
K
87
2722
EXPANDED USE FOR SHILEY 3L CARDF PLUS
2
Cleared 510(K)
K
87
2721
EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR
2
Cleared 510(K)
K
87
2720
SHILEY PTS CHEST DRAINAGE AUTOTRANSFUSION SET
2
Cleared 510(K)
K
87
2378
WILLIAM HARVEY HARDSHELL VENOUS RESERVOIR
2
Cleared 510(K)
K
87
1775
STAT-VAC CHEST DRAINAGE SYSTEM
2
Cleared 510(K)
K
87
0829
SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR
2
Cleared 510(K)
K
86
4895
INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER
2
Cleared 510(K)
K
86
2920
BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR
2
Cleared 510(K)
K
86
2357
MODIFIED CARDIOTOMY RESERVOIR 5M1470
2
Cleared 510(K)
K
85
4841
SHILEY VENOUS RESERVOIR
2
Cleared 510(K)
K
85
2382
CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR
2
Cleared 510(K)
K
85
1401
VENUOS RESERVOIR BAG BMR-1900
2
Cleared 510(K)
K
85
1376
VENOUS RESERVOIR BAG BMR-1600
2
Cleared 510(K)
K
84
2391
ACR 2500 CARDIOTOMY RESERVOIR FILTER
2
Cleared 510(K)
K
84
3888
CARDIOTOMY RESERVOIR BRS-XXX SERIES &
2
Cleared 510(K)
K
84
3595
CARDIOTOMY RESERVOIR W/FILTER
2
Cleared 510(K)
K
84
4367
CARDIOTOMY RESERVOIR W/FILTER BCR-2500
2
Cleared 510(K)
K
84
4366
CARDIOTOMY RESERVOIR BCR-2000
2
Cleared 510(K)
K
84
4229
VENOUS RESERVOIR VRS-XXX SERIES; HOLDER VRS-HXX
2
Cleared 510(K)
K
84
3232
SHILEY HARDSHELL VENOUS RESERVOIR W/INT
2
Cleared 510(K)
K
84
2620
CARDIOTOMY RESERVOIR W/FILTER BCR-3500
2
Cleared 510(K)
K
84
2337
SHILEY VENOUS RESERVOIR
2
Cleared 510(K)
K
84
2711
SHILEY CARDIOTOMY RESERVOIR W/FILTER
2
Cleared 510(K)
K
84
1938
CARDIOPLEGIA RESERVOIR CAS-2000
2
Cleared 510(K)
K
84
1031
OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT
2
Cleared 510(K)
K
84
1175
WILLIAM HARVEY H-4720 NON-FILTERED CAR
2
Cleared 510(K)
K
84
1079
WILLIAM HARVEY H-4700 FILTER/CARDIO
2
Cleared 510(K)
K
83
4373
CARDIOTOMY RESERVORS BCR-3000/3500-Q-120
2
Cleared 510(K)
K
83
2802
USE OF TWEEN 80 AS A WETTING AGENT ON
2
Cleared 510(K)
K
83
2671
CARDIOTOMY RESERVOIR-FILTER 050-108-050
2
Cleared 510(K)
K
83
3479
WILLIAM HARVEY H-71-5-F CARDIOTOMY
2
Cleared 510(K)
K
83
2924
VENOUS RESERVOIR
2
Cleared 510(K)
K
83
1966
CARDIOPLEGIA RESERVOIR-#500926
2
Cleared 510(K)
K
82
3272
VENOUS RESERVOIR BAG #BMR-1400
2
Cleared 510(K)
K
82
3205
EXV VENOUS RESERVOIR BAG & HOLDER
2
Cleared 510(K)
K
82
0727
CARDIOTOMY RESERVOIRS
2
Cleared 510(K)
K
82
1442
WILLIAM HARVEY FLEX. VENOUS RESERVOIR
2
Cleared 510(K)
K
81
3268
SC-2500F CARDIOTOMY RESERVIOR
2
Cleared 510(K)
K
81
2455
SUCKER CARDIOTOMY RETURN, C.P. BYPASS
2
Cleared 510(K)
K
81
2009
CARDIOTOMY RESERVOIR W/FILTER#BCR-3500
2
Cleared 510(K)
K
81
2008
CORDIOTOMY RESERVOIR
2
Cleared 510(K)
K
80
2890
CPS-1000
2
Cleared 510(K)
K
80
3059
INTERSEPT* VENOUS RESERVOIR BAG & HOLDER
2
Cleared 510(K)
K
80
2119
SHILEY UTILITY RESERVOIR
2
Cleared 510(K)
K
79
0635
Q220F CARDITOMY RESERVOIR/MODIFIED
2
Cleared 510(K)
K
78
1577
DISPOSABLE CARDIOTOMY; H-700F, H-700
2
Cleared 510(K)
K
78
0517
CARDIOTOMY RESERVOIR
2
Cleared 510(K)
K
77
0546
BLOOD RESERVOIR
2
Cleared 510(K)
K
77
0036
CARDIOTOMY RESERVOIR
2
Cleared 510(K)
K
76
0823
TMO OXYGENATOR RESERVOIR PUMP SET
2
Cleared 510(K)
DTP
Defoamer, Cardiopulmonary Bypass
2
Product Code
DTQ
Console, Heart-Lung Machine, Cardiopulmonary Bypass
2
Product Code
DTR
Heat-Exchanger, Cardiopulmonary Bypass
2
Product Code
DTS
Sucker, Cardiotomy Return, Cardiopulmonary Bypass
2
Product Code
DTW
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
2
Product Code
DTX
Gas Control Unit, Cardiopulmonary Bypass
2
Product Code
DTY
Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
2
Product Code
DTZ
Oxygenator, Cardiopulmonary Bypass
2
Product Code
DWA
Control, Pump Speed, Cardiopulmonary Bypass
2
Product Code
DWB
Pump, Blood, Cardiopulmonary Bypass, Roller Type
2
Product Code
DWC
Controller, Temperature, Cardiopulmonary Bypass
2
Product Code
DWD
Suction Control, Intracardiac, Cardiopulmonary Bypass
2
Product Code
DWE
Tubing, Pump, Cardiopulmonary Bypass
2
Product Code
DWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
2
Product Code
DWP
Dilator, Vessel, Surgical
2
Product Code
DWQ
Stripper, Vein, External
2
Product Code
DWS
Instruments, Surgical, Cardiovascular
1
Product Code
DWX
Stripper, Artery, Intraluminal
2
Product Code
DWZ
Device, Biopsy, Endomyocardial
2
Product Code
DXC
Clamp, Vascular
2
Product Code
DXS
Gauge, Pressure, Coronary, Cardiopulmonary Bypass
2
Product Code
JOD
Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
2
Product Code
JOR
Generator, Pulsatile Flow, Cardiopulmonary Bypass
3
Product Code
KFM
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
2
Product Code
KRI
Accessory Equipment, Cardiopulmonary Bypass
1
Product Code
KRJ
Filter, Prebypass, Cardiopulmonary Bypass
2
Product Code
KRL
Detector, Bubble, Cardiopulmonary Bypass
2
Product Code
LXN
Probe, Test, Heart-Valve
1
Product Code
MCW
Catheter, Peripheral, Atherectomy
2
Product Code
MFY
Endothelial Cell Harvesting Kit
2
Product Code
MGZ
Valvulotome
2
Product Code
MJJ
Cpb Check Valve, Retrograde Flow, In-Line
2
Product Code
MJN
Catheter, Intravascular Occluding, Temporary
2
Product Code
MNJ
Valve, Pressure Relief, Cardiopulmonary Bypass
2
Product Code
MWS
Stabilizer, Heart
1
Product Code
NCP
Cannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism Protection
2
Product Code
NLJ
Stripper, Vein, External, Reprocessed
2
Product Code
NMF
Clamp, Vascular, Reprocessed
2
Product Code
NQG
Stabilizer, Heart, Non-Compression, Reprocessed
1
Product Code
OET
Cardioplegia Solution Administration Kit
2
Product Code
OEU
Cardiopulmonary Bypass Catheter Kit
2
Product Code
OFA
Cardiovascular Surgical Instruments Tray
1
Product Code
OFG
Ct Biopsy Tray
2
Product Code
PNQ
Apical Closure Device
2
Product Code
PYX
Temporary Non-Roller Type Right Heart Support Blood Pump
3
Product Code
PTN
Reservoir, Blood, Cardiopulmonary Bypass, Exempt
2
Product Code
PZS
Dual Lumen Ecmo Cannula
2
Product Code
QJZ
Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
2
Product Code
QNR
Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
2
Product Code
QOH
Extracorporeal System For Carbon Dioxide Removal
2
Product Code
QHW
Single Lumen Ecmo Cannula
2
Product Code
QTF
Reprocessed Atherectomy Catheter
2
Product Code
QWF
Tubing, Long Term Support Greater Than 6 Hours
2
Product Code
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 23 May 2025 at 11:06 pm
CV
/
subpart-e—cardiovascular-surgical-devices
/
DTN
/
K882720
View Source
SCIMED R30 SILICONE ASSIST RESERVOIR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K882720
510(k) Type
Traditional
Applicant
SCIMED LIFE SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/16/1988
Days to Decision
77 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
Subpart E—Cardiovascular Surgical Devices
BYS
Oxygenator, Long Term Support Greater Than 6 Hours
DRY
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
DTL
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
DTM
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
DTN
Reservoir, Blood, Cardiopulmonary Bypass
K
24
1206
Quantum Perfusion Hybrid System
K
24
1053
MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL
K
22
3361
BMR 1900 PHISIO
K
17
0583
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
K
16
1733
INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
K
15
3143
Capiox Advance Hardshell Reservoir
K
15
1110
Intersept Filtered Cardiotomy Reservoir
K
14
1432
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
K
14
1233
AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE
K
14
0321
INITARY BETTER BLADDER-PEDIATRIC
K
13
2166
VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
K
13
2972
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
K
13
1103
XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
K
12
2914
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE
K
11
2771
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
K
10
2919
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE
K
10
0507
XRES BLOOD COLLECTION RESERVOIR
K
09
0690
VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
K
09
0534
VENOUS HARDSHELL CARDIOTOMY RESERVIORS
K
09
2315
SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
K
09
1062
MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
K
08
3131
MEDOS HILITE RESERVOIR, MODEL: 4030
K
08
2082
GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
K
08
1947
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
K
07
0605
JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING
K
07
2697
3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES
K
07
0839
MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR
K
06
1743
VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001
K
06
1527
CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
K
05
1606
GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING
K
05
0195
V-BAG WITH GBS COATING
K
05
0111
SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG
K
04
0023
CAPIOX FLEXIBLE VENOUS RESERVOIR
K
03
3800
CAPIOX CARDIOTOMY RESERVOIR
K
03
3714
MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING
K
03
3641
SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
K
03
1700
MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
K
03
1150
HEMOBAG, MODEL HBBSD2000
K
03
0726
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING
K
03
0449
MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
K
02
4065
SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING
K
02
2281
SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
K
02
1287
TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT
K
01
3526
CAPIOX RX HARDSHELL RESERVOIR
K
01
2942
THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500
K
00
3551
VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201
K
01
1864
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
K
00
2496
MODEL 4815 ADAPTER
K
00
2238
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
K
00
1822
THE V-BAG
K
00
1602
DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.)
K
99
4389
COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED
K
99
3001
COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED
K
99
2599
DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K
99
1973
CAPIOX SX10 HARDSHELL RESEVOIR
K
98
4586
FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS
K
99
0239
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K
98
2136
JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200
K
98
4456
COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K
98
2223
CAPIOX SX HARDSHELL RESEVOIR
K
98
0786
COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800
K
98
1284
BETTER-BLADDER (BB)
K
98
1628
BARD QUANTUM SVR MODEL NUMBER H-6440VR
K
98
0935
CAPIOX SX HARDSHELL RESERVOIR
K
97
4155
BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT
K
97
1013
CHASE TEMPERATURE PROBE
K
97
2017
BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)
K
96
4908
VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER
K
96
4907
VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT
K
97
1669
COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR
K
97
1105
MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM
K
96
4973
GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR
K
96
1836
MAXIMA FORTE HARDSHELL VENOUS RESERVOIR
K
95
3821
BIOCOR 200 HARDSHELL VENOUS RESERVIOR
K
95
5046
SOFT VENOUS RESERVOIR
K
94
5065
DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063
K
94
1215
VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR
K
93
6003
AFFINITY CVR
K
93
5717
AFFINITY VENOUS RESERVIOR BAG
K
93
4847
NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS
K
93
4763
SORIN BLOOD CARDIOPLEGIA SYSTEM
K
93
6183
SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS
K
93
3713
VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT
K
93
6286
ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)
K
93
3481
SORIN MONOLYTH VENOUS RESERVOIR
K
93
0154
EL2-SERIES BLOOD COLLECTION REERVOIR
K
93
0299
BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET
K
92
0178
CARDIOTOMY RESERVOIR W/20 MICRON FILITER
K
92
5046
PLEUR-EVAC CARDIOTOMY RESERVOIR
K
92
6250
ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR
K
91
5573
VENOUS RESERVOIR W/CARDIOTOMY FILTER
K
92
0774
MVR COLLAPSIBLE VENOUS RESERVOIR BAG
K
92
0312
NEW COBE CARDIOPLEGIA SYSTEM
K
91
5737
AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR
K
91
3915
BARD(R) WILLIAM HARVEY(R) MACRO FILT CARDIO RESERV
K
91
3956
BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30
K
91
3692
VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)
K
91
1790
MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG
K
91
1876
SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200
K
90
5818
VACUUM-ASSISTED BLOOD COLLECTION SYSTEM
K
90
3632
INTERSEPT 1375 VENOUS RESERVOIR
K
90
2631
COBE ICU CONVERSION KIT
K
90
4040
SOFTSHELL VENOUS RESERVOIR
K
89
4664
CAPIOX HARDSHELL VENOUS RESERVOIR
K
89
5356
UNIVOX-IC
K
89
3711
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K
89
6414
VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN
K
89
3705
SAFE-1 VENOUS RESERVOIR
K
89
5076
CMS VRB-1200
K
89
0077
TRAUMAFUSE RAPID INFUSION DEVICE
K
88
4872
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K
88
2414
BLOOD RESERVOIR, CARDIOPULMONARY BYPASS
K
88
3923
CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES
K
88
2380
SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR
K
88
3345
SARNS INFANT VENOUS RESERVOIR MODEL #16387
K
88
2720
SCIMED R30 SILICONE ASSIST RESERVOIR
K
87
3423
MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER
K
87
2719
EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER
K
87
2722
EXPANDED USE FOR SHILEY 3L CARDF PLUS
K
87
2721
EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR
K
87
2720
SHILEY PTS CHEST DRAINAGE AUTOTRANSFUSION SET
K
87
2378
WILLIAM HARVEY HARDSHELL VENOUS RESERVOIR
K
87
1775
STAT-VAC CHEST DRAINAGE SYSTEM
K
87
0829
SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR
K
86
4895
INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER
K
86
2920
BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR
K
86
2357
MODIFIED CARDIOTOMY RESERVOIR 5M1470
K
85
4841
SHILEY VENOUS RESERVOIR
K
85
2382
CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR
K
85
1401
VENUOS RESERVOIR BAG BMR-1900
K
85
1376
VENOUS RESERVOIR BAG BMR-1600
K
84
2391
ACR 2500 CARDIOTOMY RESERVOIR FILTER
K
84
3888
CARDIOTOMY RESERVOIR BRS-XXX SERIES &
K
84
3595
CARDIOTOMY RESERVOIR W/FILTER
K
84
4367
CARDIOTOMY RESERVOIR W/FILTER BCR-2500
K
84
4366
CARDIOTOMY RESERVOIR BCR-2000
K
84
4229
VENOUS RESERVOIR VRS-XXX SERIES; HOLDER VRS-HXX
K
84
3232
SHILEY HARDSHELL VENOUS RESERVOIR W/INT
K
84
2620
CARDIOTOMY RESERVOIR W/FILTER BCR-3500
K
84
2337
SHILEY VENOUS RESERVOIR
K
84
2711
SHILEY CARDIOTOMY RESERVOIR W/FILTER
K
84
1938
CARDIOPLEGIA RESERVOIR CAS-2000
K
84
1031
OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT
K
84
1175
WILLIAM HARVEY H-4720 NON-FILTERED CAR
K
84
1079
WILLIAM HARVEY H-4700 FILTER/CARDIO
K
83
4373
CARDIOTOMY RESERVORS BCR-3000/3500-Q-120
K
83
2802
USE OF TWEEN 80 AS A WETTING AGENT ON
K
83
2671
CARDIOTOMY RESERVOIR-FILTER 050-108-050
K
83
3479
WILLIAM HARVEY H-71-5-F CARDIOTOMY
K
83
2924
VENOUS RESERVOIR
K
83
1966
CARDIOPLEGIA RESERVOIR-#500926
K
82
3272
VENOUS RESERVOIR BAG #BMR-1400
K
82
3205
EXV VENOUS RESERVOIR BAG & HOLDER
K
82
0727
CARDIOTOMY RESERVOIRS
K
82
1442
WILLIAM HARVEY FLEX. VENOUS RESERVOIR
K
81
3268
SC-2500F CARDIOTOMY RESERVIOR
K
81
2455
SUCKER CARDIOTOMY RETURN, C.P. BYPASS
K
81
2009
CARDIOTOMY RESERVOIR W/FILTER#BCR-3500
K
81
2008
CORDIOTOMY RESERVOIR
K
80
2890
CPS-1000
K
80
3059
INTERSEPT* VENOUS RESERVOIR BAG & HOLDER
K
80
2119
SHILEY UTILITY RESERVOIR
K
79
0635
Q220F CARDITOMY RESERVOIR/MODIFIED
K
78
1577
DISPOSABLE CARDIOTOMY; H-700F, H-700
K
78
0517
CARDIOTOMY RESERVOIR
K
77
0546
BLOOD RESERVOIR
K
77
0036
CARDIOTOMY RESERVOIR
K
76
0823
TMO OXYGENATOR RESERVOIR PUMP SET
DTP
Defoamer, Cardiopulmonary Bypass
DTQ
Console, Heart-Lung Machine, Cardiopulmonary Bypass
DTR
Heat-Exchanger, Cardiopulmonary Bypass
DTS
Sucker, Cardiotomy Return, Cardiopulmonary Bypass
DTW
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
DTX
Gas Control Unit, Cardiopulmonary Bypass
DTY
Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
DTZ
Oxygenator, Cardiopulmonary Bypass
DWA
Control, Pump Speed, Cardiopulmonary Bypass
DWB
Pump, Blood, Cardiopulmonary Bypass, Roller Type
DWC
Controller, Temperature, Cardiopulmonary Bypass
DWD
Suction Control, Intracardiac, Cardiopulmonary Bypass
DWE
Tubing, Pump, Cardiopulmonary Bypass
DWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
DWP
Dilator, Vessel, Surgical
DWQ
Stripper, Vein, External
DWS
Instruments, Surgical, Cardiovascular
DWX
Stripper, Artery, Intraluminal
DWZ
Device, Biopsy, Endomyocardial
DXC
Clamp, Vascular
DXS
Gauge, Pressure, Coronary, Cardiopulmonary Bypass
JOD
Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
JOR
Generator, Pulsatile Flow, Cardiopulmonary Bypass
KFM
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
KRI
Accessory Equipment, Cardiopulmonary Bypass
KRJ
Filter, Prebypass, Cardiopulmonary Bypass
KRL
Detector, Bubble, Cardiopulmonary Bypass
LXN
Probe, Test, Heart-Valve
MCW
Catheter, Peripheral, Atherectomy
MFY
Endothelial Cell Harvesting Kit
MGZ
Valvulotome
MJJ
Cpb Check Valve, Retrograde Flow, In-Line
MJN
Catheter, Intravascular Occluding, Temporary
MNJ
Valve, Pressure Relief, Cardiopulmonary Bypass
MWS
Stabilizer, Heart
NCP
Cannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism Protection
NLJ
Stripper, Vein, External, Reprocessed
NMF
Clamp, Vascular, Reprocessed
NQG
Stabilizer, Heart, Non-Compression, Reprocessed
OET
Cardioplegia Solution Administration Kit
OEU
Cardiopulmonary Bypass Catheter Kit
OFA
Cardiovascular Surgical Instruments Tray
OFG
Ct Biopsy Tray
PNQ
Apical Closure Device
PYX
Temporary Non-Roller Type Right Heart Support Blood Pump
PTN
Reservoir, Blood, Cardiopulmonary Bypass, Exempt
PZS
Dual Lumen Ecmo Cannula
QJZ
Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
QNR
Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
QOH
Extracorporeal System For Carbon Dioxide Removal
QHW
Single Lumen Ecmo Cannula
QTF
Reprocessed Atherectomy Catheter
QWF
Tubing, Long Term Support Greater Than 6 Hours
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-e—cardiovascular-surgical-devices
/
DTN
/
K882720
View Source
SCIMED R30 SILICONE ASSIST RESERVOIR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K882720
510(k) Type
Traditional
Applicant
SCIMED LIFE SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/16/1988
Days to Decision
77 days