FDA 510(k) Cardiovascular Devices
FDA 510(k) Cardiovascular Devices - Regulatory Overview
FDA 510(k) cardiovascular devices represent one of the largest device categories, with 17,947 submissions since 1976. The FDA review panel code is CV.
This category covers a wide risk spectrum:
- Class I / II - blood pressure monitors, stethoscopes, ECG systems, holter monitors
- Class II Special Controls - catheters, guidewires, cardiac ablation systems
- Class II / III - pacemakers, implantable defibrillators, stents
Top product codes include DXN (blood pressure systems, 1,201 devices) and DQY (percutaneous catheters, 850 devices). Average FDA review time: 125 days.
18151
Total
18097
Cleared
152d
Avg (2y)
1976
Since
15012 Cardiovascular devices
Cleared
Jun 03, 1998
BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS
DSP
System, Balloon, Intra-aortic And Control
90d
Cleared
Jun 02, 1998
CS/3(TM) MONITORS*
DSI
Detector And Alarm, Arrhythmia
162d
Cleared
Jun 01, 1998
COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR
DTZ
Oxygenator, Cardiopulmonary Bypass
160d
Cleared
May 29, 1998
DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES
DSP
System, Balloon, Intra-aortic And Control
88d
Cleared
May 28, 1998
SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496
DSI
Detector And Alarm, Arrhythmia
329d
Cleared
May 28, 1998
PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT
DPW
Flowmeter, Blood, Cardiovascular
195d
Cleared
May 28, 1998
CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.
DRF
Catheter, Electrode Recording, Or Probe, Electrode Recording
73d
Cleared
May 26, 1998
MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD
LDF
Electrode, Pacemaker, Temporary
260d
Cleared
May 21, 1998
FAST-CATH (TM) INTRA-CARDIAC INTRODUCER
DYB
Introducer, Catheter
225d
Cleared
May 20, 1998
OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER
LIT
Catheter, Angioplasty, Peripheral, Transluminal
30d
Cleared
May 19, 1998
SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG)
DSI
Detector And Alarm, Arrhythmia
90d
Cleared
May 18, 1998
CRITIKON SOFT BLOOD PRESSURE CUFF
DXQ
Blood Pressure Cuff
201d
Cleared
May 15, 1998
SITESEER ANGIOGRAPHIC CATHETER
DQO
Catheter, Intravascular, Diagnostic
87d
Cleared
May 15, 1998
3M CDI QUICK-CELLS WITH HEPARIN TREATMENT
DRY
Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
79d
Cleared
May 14, 1998
BARD ISOFLOW BLOOD PUMP
DWA
Control, Pump Speed, Cardiopulmonary Bypass
393d
Cleared
May 14, 1998
CAPIOX SX HARDSHELL RESERVOIR
DTN
Reservoir, Blood, Cardiopulmonary Bypass
63d
Cleared
May 13, 1998
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
DQY
Catheter, Percutaneous
23d
Cleared
May 12, 1998
ARCHIMED 4210 AND 4220
LOS
209d
Cleared
May 12, 1998
MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE
MKJ
Automated External Defibrillators (non-wearable)
68d
Cleared
May 11, 1998
CORDIS VANGUARD STEERABLE GUIDEWIRES
DQX
Wire, Guide, Catheter
157d
Cleared
May 11, 1998
CARDIOSTATION
DXH
Transmitters And Receivers, Electrocardiograph, Telephone
82d
Cleared
May 07, 1998
MUSE CARDIOVASCULAR INFORMATION SYSTEM
LOS
87d
Cleared
May 07, 1998
VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
DYF
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
44d
Cleared
May 07, 1998
VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
DSY
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
44d
Cleared
May 05, 1998
OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR
DXW
System, Phonocatheter, Intracavitary
337d
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