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
12913–12936 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 17, 1989
DISPOSABLE CATHETER PRESSURE TRANSDUCER
K894033 · DXO
Deseret Medical, Inc.
Cardiovascular · 133d
Cleared Oct 17, 1989
LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD
K894494 · DXY
Biotronik, GmbH & Co.
Cardiovascular · 90d
Cleared Oct 17, 1989
CORDIS STEERABLE COATED GUIDEWIRE
K894633 · DQX
Cordis Corp.
Cardiovascular · 85d
Cleared Oct 17, 1989
PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT
K894684 · DWF
Pioneering Technologies, Inc.
Cardiovascular · 84d
Cleared Oct 12, 1989
FEM-FLEX FEMORAL ACCESS CANNULATION SET
K891576 · DWF
Research Medical, Inc.
Cardiovascular · 206d
Cleared Oct 12, 1989
PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)
K891786 · DWP
Pioneering Technologies, Inc.
Cardiovascular · 202d
Cleared Oct 12, 1989
HEMO-ALERT
K893830 · DQO
Koregon Enterprise, Inc.
Cardiovascular · 141d
Cleared Oct 12, 1989
P POLYMER
K893990 · LDD
Pace West
Cardiovascular · 129d
Cleared Oct 12, 1989
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
K894286 · DXO
Ppg Industries, Inc.
Cardiovascular · 111d
Cleared Oct 12, 1989
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
K894318 · DQX
Datascope Corp.
Cardiovascular · 90d
Cleared Oct 12, 1989
CARE DISP. DIAG. ELECTRODES, SILVER/SILVER
K894462 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 86d
Cleared Oct 12, 1989
OLYMPUS VALVULOTOME W/FIXED TIP
K894496 · DWX
Olympus Corp.
Cardiovascular · 85d
Cleared Oct 12, 1989
TELEMETRY RECEIVER ACCESSORY FOR THE CMS 8000
K894540 · DXH
Physio-Control Corp.
Cardiovascular · 84d
Cleared Oct 12, 1989
REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER
K894681 · DXE
Shiley, Inc.
Cardiovascular · 79d
Cleared Oct 12, 1989
VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION)
K894732 · DSY
Medtronic Vascular
Cardiovascular · 78d
Cleared Oct 12, 1989
PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH.
K894747 · DXO
Endosonics Corp.
Cardiovascular · 78d
Cleared Oct 12, 1989
CARE 5000 SYSTEM
K894858 · DSI
Care Systems, Inc.
Cardiovascular · 73d
Cleared Oct 12, 1989
ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP.
K894976 · DTD
Medtronic Vascular
Cardiovascular · 66d
Cleared Oct 12, 1989
ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES
K895032 · LDD
Zmi Corp.
Cardiovascular · 65d
Cleared Oct 12, 1989
R2 PACE ADAPTOR CABLE, MODEL 196
K895728 · DRO
Darox Corp.
Cardiovascular · 17d
Cleared Oct 12, 1989
R2 PACE PAD, MODEL 480
K895729 · DRO
Darox Corp.
Cardiovascular · 17d
Cleared Oct 03, 1989
ERGOMED 840/ERGOMED 840L
K885085 · DRT
Burdick Corp.
Cardiovascular · 298d
Cleared Oct 03, 1989
CARDIOBEEPER MEMORY MONITOR CB 600 SERIES
K894799 · DXH
Survival Technology, Inc.
Cardiovascular · 67d
Cleared Oct 03, 1989
SELECTRODE
K894920 · DRX
S & W Medico Teknik
Cardiovascular · 62d