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
1585–1608 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 07, 2021
Arterial Catheter
K201726 · DQY
Haolang Medical USA Corporation
Cardiovascular · 379d
Cleared Jul 06, 2021
SafeCross Transseptal Puncture and Introducer (TSP/I) System
K203459 · DYB
East End Medical I, LLC
Cardiovascular · 224d
Cleared Jul 02, 2021
Selethru(TM) NC PTCA Balloon Dilatation Catheter
K211393 · LOX
Kossel Medtech (Suzhou) Co., Ltd.
Cardiovascular · 58d
Cleared Jun 30, 2021
KardiaMobile 6L
K210753 · DXH
AliveCor, Inc.
Cardiovascular · 107d
Cleared Jun 30, 2021
Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50...
K210560 · DPS
Philips Medical Systems
Cardiovascular · 125d
Cleared Jun 30, 2021
Quantum Perfusion Arterial Cannula Graft
K203057 · DWF
Qura S.R.L
Cardiovascular · 265d
Cleared Jun 25, 2021
iLab Polaris Multi-Modality Guidance System
K210889 · DQK
Boston Scientific Corporation
Cardiovascular · 92d
Cleared Jun 23, 2021
Reprocessed PentaRay Nav eco High-Density Mapping Catheter
K201806 · MTD
Sterilmed Inc. (Johnson and Johnson)
Cardiovascular · 357d
Cleared Jun 16, 2021
Sublime Radial Access 018 RX Dilatation Catheter
K211044 · LIT
Creagh Medical Ltd. (A Wholly Owned...
Cardiovascular · 69d
Cleared Jun 14, 2021
2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix...
K211518 · MCW
Volcano Atheromed, Inc.
Cardiovascular · 28d
Cleared Jun 11, 2021
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
K210484 · MXD
Medtronic, Inc.
Cardiovascular · 112d
Cleared Jun 10, 2021
BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular...
K211061 · QEY
Thrombolex, Inc.
Cardiovascular · 62d
Cleared Jun 08, 2021
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
K210458 · NQQ
Abbott Medical
Cardiovascular · 112d
Cleared Jun 07, 2021
HRVWatch-Mini Wrist Monitor
K201914 · DXN
Taiwan Scientific Corporation
Cardiovascular · 333d
Cleared Jun 04, 2021
AlphaVac Multipurpose Mechanical Aspiration (MMA) System
K211081 · QEZ
AngioDynamics, Inc.
Cardiovascular · 53d
Cleared Jun 03, 2021
Breezeway II
K210627 · DYB
Oscor, Inc.
Cardiovascular · 93d
Cleared Jun 03, 2021
PCA-C1 series Patient Cable
K200722 · DSA
QT Medical, Inc.
Cardiovascular · 441d
Cleared May 28, 2021
AtriCure Isolator® Synergy™ Surgical Ablation System
K211311 · OCL
AtriCure, Inc.
Cardiovascular · 28d
Cleared May 28, 2021
LINQ II Insertable Cardiac Monitor
K211304 · MXD
Medtronic, Inc.
Cardiovascular · 29d
Cleared May 28, 2021
coraCross
K210188 · DQY
Reflow Medical
Cardiovascular · 123d
Cleared May 28, 2021
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension...
K203687 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 162d
Cleared May 27, 2021
BIB Stent Placement Catheter
K211134 · NVM
NuMED, Inc.
Cardiovascular · 41d
Cleared May 26, 2021
PlasmaWave
K211253 · JOW
Manamed, Inc.
Cardiovascular · 30d
Cleared May 26, 2021
ViperCath XC Peripheral Exchange Catheter
K211251 · DQY
Cardiovascular Systems, Inc.
Cardiovascular · 30d