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
3385–3408 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 02, 2015
Capiox Advance Hardshell Reservoir
K153143 · DTN
Terumo Cardiovascular Systems...
Cardiovascular · 33d
Cleared Dec 02, 2015
Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18...
K153140 · DTZ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 33d
Cleared Dec 02, 2015
Lantern Delivery Microcatheter
K152840 · DQY
Penumbra, Inc.
Cardiovascular · 64d
Cleared Dec 02, 2015
Attachable Cath Lab Hemostasis Valve
K152528 · DTL
Galt Medical Corp.
Cardiovascular · 90d
Cleared Dec 01, 2015
Glidesheath
K152173 · DYB
Terumo Medical Corporation
Cardiovascular · 119d
Cleared Nov 24, 2015
Edwards eSheath Introducer Set
K152225 · DYB
Edwards Lifesciences
Cardiovascular · 109d
Cleared Nov 23, 2015
Fogarty Occlusion Catheter
K152762 · MJN
Edwards Lifesciences, LLC
Cardiovascular · 60d
Cleared Nov 20, 2015
RX ACCUNET Embolic Protection System
K153086 · NTE
Abbott Vascular
Cardiovascular · 25d
Cleared Nov 19, 2015
Visions PV.014P RX Digital IVUS Catheter
K152829 · OBJ
Volcano Corporation
Cardiovascular · 51d
Cleared Nov 19, 2015
Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and...
K151791 · DTZ
Terumo Cardiovascular Systems...
Cardiovascular · 141d
Cleared Nov 18, 2015
R350 guidewire
K151234 · DQX
Vascular Solutions, Inc.
Cardiovascular · 194d
Cleared Nov 16, 2015
Radifocus Glidewire
K152740 · DQX
Ashitaka Factory of Terumo Corp.
Cardiovascular · 54d
Cleared Nov 13, 2015
AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access...
K151667 · DQY
Stryker
Cardiovascular · 147d
Cleared Nov 13, 2015
Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter
K151638 · DQY
Cathera, Inc.
Cardiovascular · 149d
Cleared Nov 12, 2015
Turbo-Power Laser Atherectomy Catheter
K152181 · MCW
Spectranetics, Inc.
Cardiovascular · 100d
Cleared Nov 10, 2015
TR BAND Radial Compression Device
K152525 · DXC
Terumo Medical Corporation
Cardiovascular · 68d
Cleared Nov 09, 2015
Wrist - Type Fully Automatic Digital Blood Pressure Monitor
K152426 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 75d
Cleared Nov 06, 2015
LILLIPUP PMP, LILLIPUT PMP INTEGRATED
K151713 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 134d
Cleared Nov 06, 2015
CerOX
K150268 · DPW
Or-Nim Medical , Ltd.
Cardiovascular · 275d
Cleared Nov 05, 2015
Nihon Kohden CSM 1901 Bedside Monitor
K151080 · MHX
Nihon Kohden
Cardiovascular · 197d
Cleared Nov 05, 2015
elance Vital Signs Monitor, Central Monitor Software
K150329 · MHX
Spacelabs Healthcare
Cardiovascular · 268d
Cleared Oct 30, 2015
Prelude SNAP Splittable Hydrophilic Sheath Introducer
K152381 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 67d
Cleared Oct 30, 2015
Philips CS770 IntelliSpace Critical Care and Anesthesia
K151366 · DXJ
Philips Medical Systems
Cardiovascular · 162d
Cleared Oct 29, 2015
Impulse Angiographic Catheter, Expo Angiographic Catheter
K152605 · DQO
Boston Scientific Corporation
Cardiovascular · 48d