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
9985–10008 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 08, 1997
MANIFOLD
K972654 · DTL
Medical Specialties Intl., Inc.
Cardiovascular · 85d
Cleared Oct 03, 1997
NIVP3 (WINDOWS VERSION OF NIVP
K970570 · DQK
D. E. Hokanson, Inc.
Cardiovascular · 231d
Cleared Oct 03, 1997
FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR
K971131 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 190d
Cleared Oct 02, 1997
THUMPER
K972525 · DRM
Michigan Instruments, Inc.
Cardiovascular · 87d
Cleared Oct 01, 1997
HEARTPORT INTRODUCER SHEATH
K972570 · DYB
Heartport, Inc.
Cardiovascular · 83d
Cleared Sep 30, 1997
5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER
K970854 · DQO
Cordis Corp.
Cardiovascular · 204d
Cleared Sep 29, 1997
COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS
K964043 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 355d
Cleared Sep 26, 1997
3M LITTMANN ELECTRONIC STETHOSCOPE
K961848 · DQD
Minnesota Mining and Mfg. Co.
Cardiovascular · 501d
Cleared Sep 26, 1997
ACS VIKING GUIDING CATHETER
K972484 · DQY
Guidant Corp.
Cardiovascular · 86d
Cleared Sep 25, 1997
SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS
K972199 · DPS
Marquette Electronics, Inc.
Cardiovascular · 106d
Cleared Sep 25, 1997
SPACELABS MEDICAL PCIS PATIENT MONITORS
K972282 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 99d
Cleared Sep 25, 1997
HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH...
K972418 · MKJ
Heartstream, Inc.
Cardiovascular · 90d
Cleared Sep 24, 1997
KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE
K971038 · DPS
Kontron Instruments , Ltd.
Cardiovascular · 188d
Cleared Sep 24, 1997
RI-MEGA
K972377 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 90d
Cleared Sep 24, 1997
SANAPHON N
K972378 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 90d
Cleared Sep 24, 1997
PRECISA N
K972379 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 90d
Cleared Sep 23, 1997
ANGIOMAT ILLUMENA
K963071 · DXT
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 412d
Cleared Sep 23, 1997
SHELHIGH PERICARDIAL PATCH
K964467 · DXZ
Shelhigh, Inc.
Cardiovascular · 320d
Cleared Sep 19, 1997
DINAMAP MPS PORTABLE MONITOR
K971569 · MSX
Johnson & Johnson Medical, Inc.
Cardiovascular · 143d
Cleared Sep 19, 1997
AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)
K971984 · MCW
Microvena Corp.
Cardiovascular · 113d
Cleared Sep 17, 1997
ACS HI-TORQUE RULER GUIDE WIRE
K972290 · DQX
Guidant Corp.
Cardiovascular · 90d
Cleared Sep 17, 1997
BIG BEN SQUARE, BIG BEN ROUND
K972301 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 90d
Cleared Sep 16, 1997
8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT...
K963865 · DSP
Arrow Intl., Inc.
Cardiovascular · 357d
Cleared Sep 15, 1997
RIVETTI-LEVINSON INSTRALUMINAL SHUNT
K972261 · DWF
Integra Neurocare, LLC
Cardiovascular · 90d