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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
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
K
17
0726
Biopsy Forceps
2
Cleared 510(K)
K
07
2051
NOVATOME, MODEL: SU101-50
2
Cleared 510(K)
K
01
0473
SPARROWHAWK DISPOSABLE
2
Cleared 510(K)
K
00
0409
MODIFICATION TO T-REX BIOPSY FORCEPS
2
Cleared 510(K)
K
99
1486
ULTRA-CBX
2
Cleared 510(K)
K
97
4175
HEARTPORT ENDOAORTIC CLAMP CATHETER
2
Cleared 510(K)
K
97
3818
T-REX BIOPSY FORCEPS
2
Cleared 510(K)
K
95
1447
DYNABITE CARDIOVASCULAR BIOPSY FORCEPS
2
Cleared 510(K)
K
93
2788
CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE
2
Cleared 510(K)
K
92
1401
BIOPSY FORCEPS
2
Cleared 510(K)
K
92
0289
CORDIS BIPAL 7 BIOPSY FORCEPS
2
Cleared 510(K)
K
91
4567
CORDIS BIPAL BIOPSY FORCEPS
2
Cleared 510(K)
K
91
0840
VASCULAR BIOPSY FORCEPS
2
Cleared 510(K)
K
90
1300
BIOPSY FORCEPS
2
Cleared 510(K)
K
89
5098
BIOPSY FORCEPS
2
Cleared 510(K)
K
89
0453
REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES
2
Cleared 510(K)
K
88
3723
FLEXIBLE MYOCARDIAL BIOPSY FORCEPS
2
Cleared 510(K)
K
88
2383
MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES
2
Cleared 510(K)
K
88
1412
MYOCARD BIOPSY FORCEP
2
Cleared 510(K)
K
87
0186
ENDOMYOCARDIAL BIOPSY DEVICE
2
Cleared 510(K)
K
81
0849
CORDIS BIOPSY FORCEPS
2
Cleared 510(K)
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 16 May 2025 at 11:05 pm
CV
/
subpart-e—cardiovascular-surgical-devices
/
DWZ
/
K914567
View Source
CORDIS BIPAL BIOPSY FORCEPS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K914567
510(k) Type
Traditional
Applicant
CORDIS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/18/1991
Days to Decision
64 days
Submission Type
Statement
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
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
K
17
0726
Biopsy Forceps
K
07
2051
NOVATOME, MODEL: SU101-50
K
01
0473
SPARROWHAWK DISPOSABLE
K
00
0409
MODIFICATION TO T-REX BIOPSY FORCEPS
K
99
1486
ULTRA-CBX
K
97
4175
HEARTPORT ENDOAORTIC CLAMP CATHETER
K
97
3818
T-REX BIOPSY FORCEPS
K
95
1447
DYNABITE CARDIOVASCULAR BIOPSY FORCEPS
K
93
2788
CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE
K
92
1401
BIOPSY FORCEPS
K
92
0289
CORDIS BIPAL 7 BIOPSY FORCEPS
K
91
4567
CORDIS BIPAL BIOPSY FORCEPS
K
91
0840
VASCULAR BIOPSY FORCEPS
K
90
1300
BIOPSY FORCEPS
K
89
5098
BIOPSY FORCEPS
K
89
0453
REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES
K
88
3723
FLEXIBLE MYOCARDIAL BIOPSY FORCEPS
K
88
2383
MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES
K
88
1412
MYOCARD BIOPSY FORCEP
K
87
0186
ENDOMYOCARDIAL BIOPSY DEVICE
K
81
0849
CORDIS BIOPSY FORCEPS
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
/
DWZ
/
K914567
View Source
CORDIS BIPAL BIOPSY FORCEPS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K914567
510(k) Type
Traditional
Applicant
CORDIS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/18/1991
Days to Decision
64 days
Submission Type
Statement