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
16201–16224 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 08, 1982
HANCOCK VASCULAR GRAFT
K820600 · DSY
Extracorporeal Medical Specialities,...
Cardiovascular · 126d
Cleared Jul 08, 1982
CARDIOTOMY RESERVOIRS
K820727 · DTN
Erik Perfusion Services
Cardiovascular · 113d
Cleared Jul 08, 1982
MITRAL VALVE ORIFICE SIZER
K820887 · DTI
Celtech
Cardiovascular · 100d
Cleared Jul 08, 1982
CARDI-O-LIFE MODEL 8823
K821090 · DPS
Amertek
Cardiovascular · 80d
Cleared Jul 08, 1982
INTRODUCER SET
K821188 · DYB
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 72d
Cleared Jul 08, 1982
MULTIPURPOSE CATHETER
K821189 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 72d
Cleared Jul 08, 1982
XOMED PATENCY MONITOR
K821373 · DPW
Xomed, Inc.
Cardiovascular · 59d
Cleared Jul 08, 1982
NON-INVASIVE AUTOMATIC BLOOD PRESSURE
K821378 · DXN
Narco Scientific
Cardiovascular · 59d
Cleared Jul 08, 1982
35MM ANGIOGRAM VIEWER ANALYZER
K821491 · DXJ
Birtcher Corp.
Cardiovascular · 51d
Cleared Jul 08, 1982
MYO/CLIP
K821518 · LDF
Alto Development Corp.
Cardiovascular · 48d
Cleared Jul 08, 1982
VITALINE DISPOSABLE EKG ELECTRODE-LEAD
K821535 · DRX
The Halverstadt Co.
Cardiovascular · 45d
Cleared Jul 08, 1982
MODEL 535-02 TRACE-A-PACE TRANSMITTER
K821726 · DXH
Intermedics, Inc.
Cardiovascular · 27d
Cleared Jul 06, 1982
D6ZO DISPOSABLE HEAT EXCHANGER
K813264 · DTR
Electromedics, Inc.
Cardiovascular · 228d
Cleared Jul 06, 1982
EXTERNAL PULSE GENERATOR - EV4542
K821791 · DTE
American Pacemaker Corp.
Cardiovascular · 19d
Cleared Jul 02, 1982
MODIFICATION OF THE PERCUTAN-BALLOON
K813355 · DSP
Smec, Inc.
Cardiovascular · 217d
Cleared Jul 02, 1982
DISPOSABLE BLOOD PRESSURE TRANSDUCER
K821416 · DRS
Bentley Laboratories, Inc.
Cardiovascular · 51d
Cleared Jul 02, 1982
TELCOR 2
K821755 · DRT
Burdick Corp.
Cardiovascular · 17d
Cleared Jul 02, 1982
QUIK - PREP2 ELECTRODE
K821757 · DRX
Quinton, Inc.
Cardiovascular · 17d
Cleared Jun 29, 1982
ARTERIAL BLOOD FILTER, #AF-1025
K820044 · DTM
Bentley Laboratories, Inc.
Cardiovascular · 173d
Cleared Jun 25, 1982
MEDILAC #SR4 & SR 40
K820256 · DSH
Spelna, Inc.
Cardiovascular · 147d
Cleared Jun 25, 1982
PHYSIOLOGICAL DISPLAY SYSTEM, MODEL 1000
K821720 · DRT
Novametrix Medical Systems, Inc.
Cardiovascular · 15d
Cleared Jun 22, 1982
C-101-P
K820939 · DXY
Coratomic, Inc.
Cardiovascular · 77d
Cleared Jun 17, 1982
MEDTRONIC A-V PACING SYSTEM ANALYZER
K812262 · DTC
Medtronic Vascular
Cardiovascular · 308d
Cleared Jun 17, 1982
ARTERIAL BLOOD FILTER MODEL #AF-1040
K820343 · DTM
Bentley Laboratories, Inc.
Cardiovascular · 129d