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
721–744 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 22, 2024
Fogarty Arterial Embolectomy Catheter with Gate Valve
K233820 · DXE
Edwards Lifesciences
Cardiovascular · 173d
Cleared May 22, 2024
Fogarty Venous Thrombectomy Catheters
K233819 · DXE
Edwards Lifesciences, LLC
Cardiovascular · 173d
Cleared May 22, 2024
Impress Angiographic Catheter
K233268 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 236d
Cleared May 20, 2024
Fogarty Corkscrew Catheters
K233619 · DXE
Edwards Lifesciences
Cardiovascular · 189d
Cleared May 17, 2024
SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
K241042 · DRC
Pressure Products Medical Device...
Cardiovascular · 30d
Cleared May 15, 2024
MVR™ Venous Reservoir Bag 800 mL
K241053 · DTN
Medtronic Cardiac Surgery
Cardiovascular · 28d
Cleared May 14, 2024
Aventus Clot Management System
K240426 · CAC
Inquis Medical
Cardiovascular · 91d
Cleared May 14, 2024
BNLE Hydrophilic Jacketed Peripheral Guidewire
K232662 · DQX
Biomerics Nle
Cardiovascular · 257d
Cleared May 09, 2024
Biofourmis Everion+ (G2)
K233418 · MSX
Biofourmis Singapore Pte., Ltd.
Cardiovascular · 212d
Cleared May 07, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6...
K240954 · PPN
Shockwave Medical, Inc.
Cardiovascular · 29d
Cleared May 07, 2024
LIFEPAK® ECG Cables
K240377 · DSA
Stryker Physio-Control
Cardiovascular · 90d
Cleared May 07, 2024
ASSURE Wearable ECG
K233864 · MWJ
Kestra Medical Technologies, Inc.
Cardiovascular · 153d
Cleared May 03, 2024
Masimo Stork
K234021 · QYU
Masimo Corporation
Cardiovascular · 135d
Cleared May 02, 2024
Siege Vascular Plug (SVP2.5-0.021)
K240261 · KRD
Merit Medical Systems, Inc.
Cardiovascular · 92d
Cleared May 02, 2024
CSF-4 (CSF-4)
K232445 · DPS
Cardiacsense
Cardiovascular · 262d
Cleared May 01, 2024
HOTWIRE™ RF Guidewire
K240900 · DXF
Atraverse Medical
Cardiovascular · 30d
Cleared May 01, 2024
AuST Steerable Sheath
K240829 · DYB
CenterPoint Systems, LLC
Cardiovascular · 36d
Cleared Apr 30, 2024
LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical...
K240156 · DSA
Physio-Control, Inc.
Cardiovascular · 102d
Cleared Apr 29, 2024
XTRA Autotransfusion System (with XTRA Bowl sets)
K240584 · CAC
Sorin Group Italia S.R.L.
Cardiovascular · 59d
Cleared Apr 29, 2024
Blood Pressure Monitor (TMB-2287-B)
K240102 · DXN
Guangdong Transtek Medical...
Cardiovascular · 104d
Cleared Apr 26, 2024
TME Temporary Myocardial Electrode
K232261 · LDF
Osypka AG
Cardiovascular · 270d
Cleared Apr 25, 2024
CDI OneView Monitoring System
K234065 · DRY
Terumo Cardiovascular Systems...
Cardiovascular · 125d
Cleared Apr 25, 2024
Portrait VSM
K233810 · MWI
Ge Medical Systems Information...
Cardiovascular · 147d
Cleared Apr 23, 2024
Provisio™ SLT IVUS™ System
K233948 · OBJ
Provisio Medical, Inc.
Cardiovascular · 131d