FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
13945–13968 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 22, 1987
CIRCAMED FULL DISCLOSURE SYSTEM
K871251 · DSI
Circadian, Inc.
Cardiovascular · 53d
Cleared May 22, 1987
ACS ENHANCED-TORQUE CORONARY GUIDING CATHETER
K871425 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 44d
Cleared May 22, 1987
IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01
K871580 · DTB
Intermedics, Inc.
Cardiovascular · 29d
Cleared May 21, 1987
IMPLANTABLE ELECTRODE LEAD, MODEL 030-439
K864618 · DTB
Telectronics, Inc.
Cardiovascular · 178d
Cleared May 21, 1987
ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY
K870357 · DTB
Intermedics, Inc.
Cardiovascular · 112d
Cleared May 21, 1987
C150-P ECG CABLES
K870926 · DPS
Desco Industries, Inc.
Cardiovascular · 73d
Cleared May 21, 1987
SARNS 9000 HEART-LUNG CONSOLE
K871131 · DTQ
3M Health Care, Sarns
Cardiovascular · 62d
Cleared May 21, 1987
MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER
K871625 · DTB
Intermedics, Inc.
Cardiovascular · 24d
Cleared May 20, 1987
FAST-PATCH(TM)
K871224 · LDD
Physio-Control Corp.
Cardiovascular · 54d
Cleared May 19, 1987
DMI AMBULATORY HOLTER MONITOR
K871045 · DSH
Diagnostic Medical Instruments
Cardiovascular · 63d
Cleared May 14, 1987
MEDTRONIC MODEL 4220 AMBULATORY ECG MONITOR
K870652 · DXH
Medtronic Vascular
Cardiovascular · 86d
Cleared May 14, 1987
SIMPSON PERIPHERAL ATHEROCATH(TM)
K871011 · LIT
Devices For Vascular Intervention, Inc.
Cardiovascular · 62d
Cleared May 12, 1987
DSP100 CAROTID PHONOANGIOGRAPHY MODULE
K864429 · DQC
Intl. Acoustics, Inc.
Cardiovascular · 181d
Cleared May 12, 1987
40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER
K864567 · DSP
Aries Medical, Inc.
Cardiovascular · 174d
Cleared May 12, 1987
40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER
K864568 · DSP
Aries Medical, Inc.
Cardiovascular · 174d
Cleared May 12, 1987
HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE
K871135 · LDD
First Medical Devices Corp.
Cardiovascular · 53d
Cleared May 12, 1987
HEARTSTART 2000, MANUAL DEFIBRILLATOR
K871136 · LDD
First Medical Devices Corp.
Cardiovascular · 53d
Cleared May 12, 1987
CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO
K871412 · DRX
Contour Electrodes, Inc.
Cardiovascular · 34d
Cleared May 11, 1987
APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)
K864260 · DRX
Grandcor Medical Systems
Cardiovascular · 194d
Cleared May 11, 1987
CARDIAC PERFORMANCE MONITOR
K864583 · DQK
Vascular Technology Incorporated
Cardiovascular · 172d
Cleared May 11, 1987
3MHZ ANNULAR ARRAY
K864980 · JOP
Philips Ultrasound, Inc.
Cardiovascular · 140d
Cleared May 11, 1987
RECORD KEEPING/DATA MANAGEMENT SYSTEM
K865035 · DQK
Critical Care Systems, Inc.
Cardiovascular · 139d
Cleared May 11, 1987
IVR-SP CUSTOM ANGIOGRAPHY TRAY
K870419 · DQO
North Coast Medi-Tek
Cardiovascular · 97d
Cleared May 07, 1987
MINGOGRAF 740 - MODEL #91-54-634
K864575 · LOS
Siemens Medical Solutions USA, Inc.
Cardiovascular · 168d