FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
12457–12480 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 22, 1990
PERCUTANEOUS INTRODUCERS
K903530 · DYB
Davol, Inc.
Cardiovascular · 77d
Cleared Oct 22, 1990
DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS
K904414 · DSP
Datascope Corp.
Cardiovascular · 63d
Cleared Oct 19, 1990
INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER
K900710 · KRB
Intec Medical, Inc.
Cardiovascular · 247d
Cleared Oct 19, 1990
ARTERIAL EMBOLECTOMY CATHETER
K901627 · DXE
Applied Vascular Devices, Inc.
Cardiovascular · 193d
Cleared Oct 19, 1990
THE GUIDER CORONARY GUIDING CATHETER
K903216 · DQY
Intec Medical, Inc.
Cardiovascular · 88d
Cleared Oct 19, 1990
TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER
K903217 · DQY
Intec Medical, Inc.
Cardiovascular · 88d
Cleared Oct 19, 1990
PYMAH PRE-GAGED BALANCED TEMPA-KUFF
K903379 · DXQ
Pymah Corp.
Cardiovascular · 81d
Cleared Oct 19, 1990
SARNS MEMBRANE OXGENATOR PART NUMBER 9443
K903436 · DTZ
3M Health Care, Sarns
Cardiovascular · 80d
Cleared Oct 19, 1990
PERCOR STAT DL 9.5 FR 34CC INTRA-AORTIC BALLOON
K903769 · DSP
Datascope Corp.
Cardiovascular · 60d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT DL 10.5 FR 40CC
K903867 · DSP
Datascope Corp.
Cardiovascular · 58d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT 8.5 FR 40CC INTRA-AORTIC BAL
K903892 · DSP
Datascope Corp.
Cardiovascular · 58d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL
K903893 · DSP
Datascope Corp.
Cardiovascular · 58d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA-AOR BAL
K904018 · DSP
Datascope Corp.
Cardiovascular · 50d
Cleared Oct 16, 1990
MEDI-TECH DILATATION CATHETERS ULTRA THIN II
K897106 · LIT
Boston Scientific Corp
Cardiovascular · 299d
Cleared Oct 16, 1990
MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11
K900607 · DSI
Cardiodata Corp.
Cardiovascular · 250d
Cleared Oct 16, 1990
FOGARTY VESSEL CALIBRATOR
K902143 · DWP
Baxter Healthcare Corp
Cardiovascular · 154d
Cleared Oct 16, 1990
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491
K902342 · LDF
Medtronic Vascular
Cardiovascular · 144d
Cleared Oct 16, 1990
LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE
K902518 · DTM
Pall Biomedical Products Co.
Cardiovascular · 132d
Cleared Oct 16, 1990
DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABL
K902932 · DYB
Datascope Corp.
Cardiovascular · 105d
Cleared Oct 16, 1990
GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY
K903840 · DYB
Intec Medical, Inc.
Cardiovascular · 56d
Cleared Oct 16, 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP
K903927 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 57d
Cleared Oct 16, 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP
K903928 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 57d
Cleared Oct 16, 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP
K903929 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 57d
Cleared Oct 12, 1990
FRANZ(TM) STEERABLE COMBINATION CATHETER
K903880 · DRF
Ep Technologies, Inc.
Cardiovascular · 51d