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
14593–14616 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 10, 1986
MA-1 VOLUME VENTIALTOR
K854843
Puritan Bennett Corp.
Cardiovascular · 68d
Cleared Feb 10, 1986
DISPOSABLE MANIFOLD
K854960 · DTL
Utah Medical Products, Inc.
Cardiovascular · 61d
Cleared Feb 06, 1986
CARDIMAX FX-1164
K853979 · DPS
Brentwood Instruments, Inc.
Cardiovascular · 133d
Cleared Feb 04, 1986
CARDIMAX FX-406U
K854505 · DRS
Brentwood Instruments, Inc.
Cardiovascular · 84d
Cleared Jan 27, 1986
CUSTO PORT 24-H ECG AMBULATORY RECORDER
K854115 · DSI
Versacor, Inc.
Cardiovascular · 111d
Cleared Jan 22, 1986
MODEL TRC-40 TELEMETRY RECIEVER MODULE
K851623 · DXH
Eaton Medical Group
Cardiovascular · 279d
Cleared Jan 22, 1986
INTRA-AORTIC BALLOON PUMP MODEL K2000
K853062 · DSP
Kontron Instruments, Inc.
Cardiovascular · 187d
Cleared Jan 22, 1986
CMS 8000
K853096 · DXH
Physio-Control Corp.
Cardiovascular · 183d
Cleared Jan 22, 1986
TELEMETRY WAND MODEL
K855171 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 27d
Cleared Jan 21, 1986
ESCORT ECG MONITOR SIEMENS SIRECUST 466
K854234 · DPS
Medical Data Electronics
Cardiovascular · 92d
Cleared Jan 16, 1986
BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT
K853652 · DRR
Fisher Imaging Corp.
Cardiovascular · 135d
Cleared Jan 16, 1986
ANGIOGRAPHY CATHETERS
K854018 · DQO
Micor, Inc.
Cardiovascular · 108d
Cleared Jan 16, 1986
IMPLANTABLE PROGRAMMABLE PULSE GENERATOR
K854560 · DXY
Telectronics, Inc.
Cardiovascular · 63d
Cleared Jan 16, 1986
SEAMED MODEL 4000
K854648 · DTE
Seamed Corp.
Cardiovascular · 58d
Cleared Jan 15, 1986
DIAGNOSTIC INTRAVASCULAR CATHETERS
K853182 · DQO
Mallinckrodt Critical Care
Cardiovascular · 169d
Cleared Jan 15, 1986
DNR UNIPOLAR
K853568 · DTB
Biotronik Sales, Inc.
Cardiovascular · 142d
Cleared Jan 15, 1986
NOVA ARTERIAL EMBOLECTOMY CATHETER
K853625 · DXE
Nova Medical Specialties
Cardiovascular · 139d
Cleared Jan 15, 1986
STYLET INTRODUCER FUNNEL
K854142 · DTB
Telectronics, Inc.
Cardiovascular · 96d
Cleared Jan 15, 1986
MEDSURG POTT-COURNAND NEEDLE
K854293 · DRC
Medsurg Industries, Inc.
Cardiovascular · 82d
Cleared Jan 15, 1986
ELECATH PULSATILE PERFUSION PUMP
K854975 · KFM
Electro-Catheter Corp.
Cardiovascular · 34d
Cleared Jan 14, 1986
MODEL TT-185 TELEMETRY TRANSMITTER
K851624 · DXH
Eaton Medical Group
Cardiovascular · 271d
Cleared Jan 14, 1986
CORDIS MULTICOR ST, MODEL 350A
K851968 · DXY
Cordis Corp.
Cardiovascular · 252d
Cleared Jan 14, 1986
ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER
K852641 · DXY
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 208d
Cleared Jan 14, 1986
COMFORT - CUF
K852978 · DXN
Dynasty Instruments, Ltd.
Cardiovascular · 183d