FDA Review Panel · CV

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
14947 Cardiovascular devices
7576–7600 of 14947
Cleared Jun 18, 2004
VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP
K040730 · Vascular Solutions, Inc.
DXC · Clamp, Vascular · 88d
Cleared Jun 18, 2004
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K040830 · NuMED, Inc.
DQO · Catheter, Intravascular, Diagnostic · 79d
Cleared Jun 18, 2004
STABIL-O-GRAPH
K041313 · I.E.M. GmbH
DXN · System, Measurement, Blood-pressure, Non-invasive · 32d
Cleared Jun 10, 2004
NUMED PTS X SIZING BALLOON CATHETER
K041306 · NuMED, Inc.
MJN · Catheter, Intravascular Occluding, Temporary · 24d
Cleared Jun 07, 2004
QUANTIX OR VESSEL STABILIZER DEVICE
K041180 · Cardiosonix, Ltd.
DPW · Flowmeter, Blood, Cardiovascular · 32d
Cleared Jun 07, 2004
DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
K041281 · Datascope Corp.
DSP · System, Balloon, Intra-aortic And Control · 25d
Cleared Jun 04, 2004
MODIFICATION TO UNITY NETWORK ID
K040559 · Ge Medical Systems Information Technologies
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 93d
Cleared Jun 04, 2004
PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS
K041235 · Philips Medizin Systeme Boeblingen GmbH
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 24d
Cleared Jun 04, 2004
MODIFICATION TO M2376A DEVICELINK SYSTEM
K041401 · Philips Medical Systems
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 9d
Cleared Jun 03, 2004
FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM
K033711 · Fukuda Denshi USA, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 190d
Cleared Jun 03, 2004
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
K040458 · Ge Medical Systems Information Technologies
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 101d
Cleared Jun 02, 2004
COMBOMAP PRESSURE AND FLOW SYSTEM
K041134 · Volcano Therapeutics, Inc.
OBJ · Catheter, Ultrasound, Intravascular · 33d
Cleared Jun 01, 2004
CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS
K033048 · Cas Medical Systems, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 246d
Cleared Jun 01, 2004
CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES
K040395 · Nihon Kohden America, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 105d
Cleared Jun 01, 2004
MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM
K040713 · Thomas Medical Products, Inc.
DYB · Introducer, Catheter · 75d
Cleared Jun 01, 2004
EXPORT CATHETER
K040869 · Medtronic Vascular
QEZ · Aspiration Thrombectomy Catheter · 60d
Cleared May 26, 2004
FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR
K040246 · Fukuda Denshi USA, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 113d
Cleared May 25, 2004
TRANSXCHANGE SUPPORT CATHETER
K033540 · Medtronic Vascular
DQY · Catheter, Percutaneous · 197d
Cleared May 25, 2004
HEARTSINE SAMARITAN PAD
K041067 · Heartsine Technologies, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 32d
Cleared May 21, 2004
ZOLL AED PLUS
K033474 · Zoll Medical Corp
MKJ · Automated External Defibrillators (non-wearable) · 200d
Cleared May 21, 2004
RINSPIRATION SYSTEM
K041291 · Kerberos Proximal Solutions, Inc.
DQO · Catheter, Intravascular, Diagnostic · 7d
Cleared May 20, 2004
GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR
K040829 · Vascutek, Ltd.
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 50d
Cleared May 19, 2004
A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR
K040371 · A&D Engineering, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 92d
Cleared May 18, 2004
GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM
K031357 · Possis Medical, Inc.
MJN · Catheter, Intravascular Occluding, Temporary · 384d
Cleared May 18, 2004
ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT
K040013 · Possis Medical, Inc.
QEZ · Aspiration Thrombectomy Catheter · 134d

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All categories 14947 DXN System, Measurement, Blood-pressure, Non-invasive 938 DQY Catheter, Percutaneous 792 DQX Wire, Guide, Catheter 701 DYB Introducer, Catheter 637 DPS Electrocardiograph 443 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 413 DQO Catheter, Intravascular, Diagnostic 402 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 377 LIT Catheter, Angioplasty, Peripheral, Transluminal 365 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 336 DSI Detector And Alarm, Arrhythmia 309 JOW Sleeve, Limb, Compressible 287 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 274