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
9601–9624 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 08, 1999
GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL...
K982272 · DQX
Biotronik, Inc.
Cardiovascular · 193d
Cleared Jan 07, 1999
MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M
K984435 · KRH
Medtronic Vascular
Cardiovascular · 27d
Cleared Jan 04, 1999
HEWLETT-PACKARD M1205A VIRIDIA 24 CT
K981376 · DSI
Hewlett-Packard Co.
Cardiovascular · 263d
Cleared Dec 30, 1998
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20,...
K983055 · LIT
Guidant Corp.
Cardiovascular · 120d
Cleared Dec 23, 1998
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K984500 · DYB
Cordis Corp.
Cardiovascular · 6d
Cleared Dec 22, 1998
CS/3 COMPACT AIRWAY MODULE, M-COVX
K982091 · MHX
Datex-Engstrom, Inc.
Cardiovascular · 190d
Cleared Dec 22, 1998
RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D
K983653 · DRF
Cardiac Pathways Corp.
Cardiovascular · 64d
Cleared Dec 17, 1998
HEARTSTREAM ELECTRODE ADAPTER
K984286 · MKJ
Hewlett-Packard Co.
Cardiovascular · 16d
Cleared Dec 15, 1998
DISTAFLO BYPASS GRAFT
K983769 · DYF
Impra, Inc.
Cardiovascular · 50d
Cleared Dec 14, 1998
MS-900S, MS-900SPM & MS-900SFM
K980845 · DXN
Mars Medical Products
Cardiovascular · 285d
Cleared Dec 14, 1998
RTM DVT PROSOFT CUFF MODEL NUMBER PS100
K981643 · JOW
R.T. Medical Services, Inc.
Cardiovascular · 220d
Cleared Dec 11, 1998
SILVERSTREAK HYDROPHILIC GUIDEWIRE
K982543 · DQX
Micro Therapeutics, Inc.
Cardiovascular · 143d
Cleared Dec 10, 1998
MEDTRONIC ANGIOGRAPHIC CATHETER
K980973 · DQO
Medtronics Interventional Vascular
Cardiovascular · 269d
Cleared Dec 09, 1998
K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60
K981737 · MKJ
Katecho, Inc.
Cardiovascular · 205d
Cleared Dec 03, 1998
MONITOR ONE NDX
K972991 · DPS
Qmed, Inc.
Cardiovascular · 478d
Cleared Dec 02, 1998
PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000
K983026 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 93d
Cleared Dec 01, 1998
VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE
K974259 · DWF
Edwards Lifesciences Research Medical
Cardiovascular · 383d
Cleared Dec 01, 1998
PERIPHERAL VASCULAR DILATOR
K974617 · DRE
Endovascular Instruments, Inc.
Cardiovascular · 355d
Cleared Nov 30, 1998
BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB
K982797 · DYB
Luther Medical Products, Inc.
Cardiovascular · 112d
Cleared Nov 25, 1998
ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003
K981802 · MKJ
Bio-Detek, Inc.
Cardiovascular · 188d
Cleared Nov 25, 1998
ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500
K982104 · MLD
Medical Data Electronics
Cardiovascular · 163d
Cleared Nov 24, 1998
BAXTER HEMOSTASIS VALVE INTRODUCERS
K981909 · DYB
Baxter Edwards
Cardiovascular · 176d
Cleared Nov 24, 1998
INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID...
K983819 · DSY
Intervascular, Inc.
Cardiovascular · 26d
Cleared Nov 24, 1998
DISTAFLO BYPASS GRAFT
K983861 · DSY
Impra, Inc.
Cardiovascular · 22d