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
15153 Cardiovascular devices
Cleared
May 31, 1988
EPICARDIA LE/FD
DQK
Computer, Diagnostic, Programmable
35d
Cleared
May 26, 1988
CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015
DQT
Occluder, Catheter Tip
86d
Cleared
May 26, 1988
MEADOX INTRA-AORTIC GRAFT
DSY
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
62d
Cleared
May 25, 1988
SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD
DYG
Catheter, Flow Directed
208d
Cleared
May 25, 1988
MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
DTB
Permanent Pacemaker Electrode
160d
Cleared
May 25, 1988
MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT
DTB
Permanent Pacemaker Electrode
34d
Cleared
May 24, 1988
MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
DTB
Permanent Pacemaker Electrode
166d
Cleared
May 24, 1988
8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM
DWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
88d
Cleared
May 24, 1988
STOCKERT-SHILEY BUBBLE MONITOR 23-23-01
DRY
Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
76d
Cleared
May 20, 1988
BIOSOUND MMI ULTRASOUND
JOP
Transducer, Ultrasonic
403d
Cleared
May 18, 1988
INTRA-AORTIC BALLOON PUMP MODEL KAAT
DSP
System, Balloon, Intra-aortic And Control
163d
Cleared
May 18, 1988
GORE-TEX VASCULAR GRAFT
DSY
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
120d
Cleared
May 18, 1988
EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET
DTI
Sizer, Heart-valve, Prosthesis
57d
Cleared
May 18, 1988
MODEL 375 ECG
DPS
Electrocardiograph
50d
Cleared
May 18, 1988
GORE-TEX VASCULAR GRAFT
DYF
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
26d
Cleared
May 13, 1988
STAT-SAT
DRY
Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
171d
Cleared
May 13, 1988
RM-301 PATIENT MONITOR
DRT
Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
98d
Cleared
May 13, 1988
INJECTOR HANDLE WITH SYRINGE
DXT
Injector And Syringe, Angiographic
66d
Cleared
May 11, 1988
ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.
DPT
Probe, Blood-flow, Extravascular
166d
Cleared
May 11, 1988
SHILEY BCD PLUS HEAT EXCHANGER
DTR
Heat-exchanger, Cardiopulmonary Bypass
83d
Cleared
May 11, 1988
DATALOGGER CHART RECORDER
DSF
Recorder, Paper Chart
75d
Cleared
May 10, 1988
PYTHON AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
DXN
System, Measurement, Blood-pressure, Non-invasive
159d
Cleared
May 10, 1988
OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOR
DXN
System, Measurement, Blood-pressure, Non-invasive
89d
Cleared
May 09, 1988
MEDSURG 16 GA. CENTRAL VEIN CATHETERIZATION TRAY
DWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
73d
Cleared
May 06, 1988
VSM(R) R2 PAPER CHART RECORDER
DSF
Recorder, Paper Chart
87d
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