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.
18110
Total
18057
Cleared
149d
Avg (2y)
1976
Since
14963 Cardiovascular devices
Cleared
Jun 12, 2002
BD INTROSYTE PRECISION INTRODUCER
DYB
Introducer, Catheter
90d
Cleared
Jun 06, 2002
VALVED PEELABLE INTRODUCER
DYB
Introducer, Catheter
70d
Cleared
Jun 06, 2002
MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE
OCL
Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
69d
Cleared
Jun 06, 2002
ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840
DSP
System, Balloon, Intra-aortic And Control
30d
Cleared
Jun 04, 2002
PHYSIOLOG, SERIES 95000
DQK
Computer, Diagnostic, Programmable
267d
Cleared
Jun 03, 2002
SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117
DQX
Wire, Guide, Catheter
82d
Cleared
Jun 03, 2002
CHARE CARIOVASCULAR PATCH
DXZ
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
56d
Cleared
May 31, 2002
EN-SNARE ENDOVASCULAR SNARE AND CATHETER
MMX
Device, Percutaneous Retrieval
15d
Cleared
May 30, 2002
ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A
DQY
Catheter, Percutaneous
15d
Cleared
May 30, 2002
ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218
DQY
Catheter, Percutaneous
15d
Cleared
May 24, 2002
UNITY IS PATIENT VIEWER
MSX
System, Network And Communication, Physiological Monitors
84d
Cleared
May 22, 2002
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I
DXN
System, Measurement, Blood-pressure, Non-invasive
34d
Cleared
May 22, 2002
MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM
DQX
Wire, Guide, Catheter
26d
Cleared
May 22, 2002
DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N
MWI
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
16d
Cleared
May 22, 2002
PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
KRA
Catheter, Continuous Flush
7d
Cleared
May 21, 2002
MEDAMICUS AXIA RSN
DYB
Introducer, Catheter
90d
Cleared
May 17, 2002
Z3 GUIDE CATHETER
DQY
Catheter, Percutaneous
28d
Cleared
May 16, 2002
CONSTELLATION CATHETERS, MODEL 8031M
MTD
Catheter, Intracardiac Mapping, High-density Array
28d
Cleared
May 15, 2002
HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE
DQX
Wire, Guide, Catheter
27d
Cleared
May 15, 2002
PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
12d
Cleared
May 08, 2002
MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
DXE
Catheter, Embolectomy
70d
Cleared
May 08, 2002
MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B
DSI
Detector And Alarm, Arrhythmia
14d
Cleared
May 07, 2002
ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.
DSI
Detector And Alarm, Arrhythmia
18d
Cleared
May 07, 2002
TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT
DTN
Reservoir, Blood, Cardiopulmonary Bypass
14d
Cleared
May 07, 2002
MODIFICATION OF APEXPRO TELEMETRY SYSTEM
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
11d
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