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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,151 results
11233–11256 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 17, 1994
PLATINUM PLUS GUIDEWIRE
K935997 · DQX
Boston Scientific Corp
Cardiovascular · 184d
Cleared Jun 15, 1994
SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T
K930876 · DTB
Siemens-Pacesetter, Inc.
Cardiovascular · 481d
Cleared Jun 14, 1994
PRESSURE MONITORING EXTENSION
K942482 · DQO
Surgical Technologies, Inc.
Cardiovascular · 20d
Cleared Jun 13, 1994
DYE MANAGEMENT SYSTEM
K941254 · DQO
Abbott Laboratories
Cardiovascular · 94d
Cleared Jun 10, 1994
SCHNEIDER GUIDEZILLA SOFTIP GUIDING CATHETER
K935292 · DQY
Boston Scientific Scimed, Inc.
Cardiovascular · 220d
Cleared Jun 09, 1994
K-SNAP
K940586 · DRX
Katecho, Inc.
Cardiovascular · 121d
Cleared Jun 08, 1994
LIFEPAK 300 AUTOMATIC ADVISORY DEFRILLATOR
K925936 · MKJ
Physio-Control Corp.
Cardiovascular · 579d
Cleared Jun 07, 1994
CATH-SEAL
K935077 · DYB
Universal Medical Instrument Corp.
Cardiovascular · 228d
Cleared Jun 06, 1994
MARINR SERIES EP DIAGNOSTIC CATHETERS
K931794 · DRF
Medtronic Cardiorhythm
Cardiovascular · 420d
Cleared Jun 06, 1994
MODEL T131 MEMORY TRANSMITTER
K933021 · DXH
Biometric Products, Inc.
Cardiovascular · 349d
Cleared Jun 02, 1994
BARD(R) EXPANDED PTFE VASCULAR GRAFT
K940816 · DSY
C.R. Bard, Inc.
Cardiovascular · 100d
Cleared May 31, 1994
TRANSIT INFUSION CATHETER
K936260 · DQO
Cordis Corp.
Cardiovascular · 152d
Cleared May 31, 1994
CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES
K941485 · DQX
Cardio Metrics, Inc.
Cardiovascular · 64d
Cleared May 27, 1994
PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS
K931444 · DTZ
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 431d
Cleared May 24, 1994
SARNS ULTRASONIC AIR SENSOR
K940651 · KRL
3M Health Care, Sarns
Cardiovascular · 98d
Cleared May 24, 1994
SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER
K940795 · DYG
Baxter Edwards
Cardiovascular · 91d
Cleared May 24, 1994
SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING
K941895 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 36d
Cleared May 19, 1994
BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER
K930745 · LIT
B.Braun Medical, Inc.
Cardiovascular · 461d
Cleared May 19, 1994
MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES
K936247 · DRC
Medicon Instruments, Inc.
Cardiovascular · 140d
Cleared May 18, 1994
GORE-TEX CARDIOVASCULAR PATCH
K940906 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 83d
Cleared May 17, 1994
AOR-TEX VASCULAR GRAFT
K933987 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 273d
Cleared May 17, 1994
HP M1175A, M1176A, COMPONENT MONITORING SYSTEM
K941811 · DPS
Hewlett-Packard Co.
Cardiovascular · 35d
Cleared May 13, 1994
REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8
K934638 · JOP
Koven Technology, Inc.
Cardiovascular · 231d
Cleared May 12, 1994
SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION
K934541 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 238d