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
6361–6384 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 08, 2008
SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS
K072947 · LIT
ClearStream Technologies , Ltd.
Cardiovascular · 113d
Cleared Feb 08, 2008
OCCLUSION BALLOON CATHETER
K070126 · DQY
Sentreheart, Inc.
Cardiovascular · 388d
Cleared Feb 07, 2008
HUMAN HEART VALVE, CRYOVALVE SG
K033484 · OHA
Cryolife, Inc.
Cardiovascular · 1556d
Cleared Feb 05, 2008
MODIFICATION TO:HEALTH BUDDY APPLIANCE
K080091 · DRG
Health Hero Network, Inc.
Cardiovascular · 22d
Cleared Feb 01, 2008
SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE
K080106 · DRX
Leonhard Lang GmbH
Cardiovascular · 17d
Cleared Feb 01, 2008
GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582
K073200 · DQO
Vascular Solutions, Inc.
Cardiovascular · 80d
Cleared Feb 01, 2008
AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC
K070985 · DSB
Osypka Medical, Inc.
Cardiovascular · 301d
Cleared Jan 31, 2008
MODIFICATION TO PROXIS SYSTEM
K073563 · NFA
St Jude Medical
Cardiovascular · 43d
Cleared Jan 31, 2008
18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION...
K073559 · DQR
Edwards Lifesciences Research Medical
Cardiovascular · 43d
Cleared Jan 31, 2008
VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER
K072798 · LIT
Abbott Vascular-Vascular Solutions
Cardiovascular · 122d
Cleared Jan 30, 2008
HERO VASCULAR ACCESS DEVICE
K071778 · DSY
Graftcath, Inc.
Cardiovascular · 212d
Cleared Jan 30, 2008
ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL...
K070514 · DTK
Aln Implants Chirurgicaux
Cardiovascular · 342d
Cleared Jan 28, 2008
PEGASUS STEERABLE (PTCA) GUIDEWIRE
K073655 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 33d
Cleared Jan 28, 2008
IMPULSE 6000D/7000DP
K072114 · DRL
Fluke Biomedical
Cardiovascular · 180d
Cleared Jan 25, 2008
OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM
K073656 · MUD
Hypermed, Inc.
Cardiovascular · 30d
Cleared Jan 25, 2008
MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM
K073625 · DPS
Ge Healthcare Systems Information...
Cardiovascular · 30d
Cleared Jan 24, 2008
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
K073441 · QEZ
Possis Medical, Inc.
Cardiovascular · 48d
Cleared Jan 24, 2008
LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500
K072596 · MKJ
Amco International Manufacturing &...
Cardiovascular · 132d
Cleared Jan 23, 2008
JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL...
K071774 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 208d
Cleared Jan 22, 2008
TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)
K072770 · LDF
Oscor, Inc.
Cardiovascular · 116d
Cleared Jan 22, 2008
I-PAD
K062970 · MKJ
Cu Medical Systems, Inc.
Cardiovascular · 480d
Cleared Jan 18, 2008
NICOM ELECTRODES
K071631 · DXG
Cheetah Medical, Inc.
Cardiovascular · 218d
Cleared Jan 16, 2008
PORTABLE ECSCOPE 12I
K080036 · DPS
Dyansys, Inc.
Cardiovascular · 9d
Cleared Jan 16, 2008
BIPORE BALLOON DILATION CATHETER
K073318 · LIT
Bipore, Inc.
Cardiovascular · 51d