FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
7921–7944 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 22, 2003
SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
K031692 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 81d
Cleared Aug 22, 2003
CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200
K032068 · DTR
Cardiovention, Inc.
Cardiovascular · 50d
Cleared Aug 22, 2003
Trellis Reserve Infusion System
K032261 · QEY
Bacchus Vascular, Inc.
Cardiovascular · 30d
Cleared Aug 22, 2003
SPIDERVIEW
K032466 · MWJ
Ela Medical, Inc.
Cardiovascular · 11d
Cleared Aug 20, 2003
QUANTIX/OR DEVICE
K030357 · DPW
Cardiosonix, Ltd.
Cardiovascular · 198d
Cleared Aug 20, 2003
EP-WORKMATE WITH RPM SYSTEM
K032225 · DQK
Ep Medsystems
Cardiovascular · 30d
Cleared Aug 19, 2003
NX SYSTEM
K030222 · DRG
American Telecare, Inc.
Cardiovascular · 209d
Cleared Aug 19, 2003
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH...
K031433 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 105d
Cleared Aug 15, 2003
MODIFICATION TO: APEXPRO TELEMETRY SYSTEM
K032369 · MHX
Ge Medical Systems Information...
Cardiovascular · 14d
Cleared Aug 13, 2003
PBN GUIDEWIRES
K031442 · DQX
Medical Device Technologies, Inc.
Cardiovascular · 99d
Cleared Aug 13, 2003
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
K032073 · DYB
W.L. Gore & Associates, Inc.
Cardiovascular · 41d
Cleared Aug 13, 2003
CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
K032370 · DSI
Ge Medical Systems Information...
Cardiovascular · 12d
Cleared Aug 12, 2003
PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES
K032146 · DQX
Precision Vascular Systems, Inc.
Cardiovascular · 29d
Cleared Aug 11, 2003
CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
K031636 · DSP
Datascope Corp.
Cardiovascular · 76d
Cleared Aug 08, 2003
ELECTROPHYSIOLOGY CATHETER
K030109 · NLH
Alliance Medical Corp.
Cardiovascular · 207d
Cleared Aug 08, 2003
PERIVAC KIT
K032050 · DQX
Boston Scientific Corp
Cardiovascular · 37d
Cleared Aug 08, 2003
DATACAPTOR
K032142 · MWI
Capsule Technologie
Cardiovascular · 25d
Cleared Aug 07, 2003
AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)
K030316 · DRX
Inovise Medical, Inc.
Cardiovascular · 189d
Cleared Aug 07, 2003
HEATER COOLER UNIT, MODEL HCU 30
K031544 · DWC
Jostra AB
Cardiovascular · 83d
Cleared Aug 07, 2003
CORRESTORE PATCH SYSTEM
K031586 · DXZ
Somanetics Corp.
Cardiovascular · 78d
Cleared Aug 07, 2003
ECHELON MICRO CATHETER, MODEL 105-5091
K031992 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 41d
Cleared Aug 06, 2003
CARDIOQ, MODEL 9051-7005
K031706 · DPW
Deltex Medical
Cardiovascular · 65d
Cleared Aug 05, 2003
LIFESYNE SYSTEMS
K030795 · DRG
Gmp/Companies, Inc.
Cardiovascular · 146d
Cleared Aug 05, 2003
UNITY NETWORK IS PATIENT VIEWER
K032346 · MSX
Ge Medical Systems Information...
Cardiovascular · 6d