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
8281–8304 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 13, 2002
PTA AND PTV
K022722 · DQY
NuMED, Inc.
Cardiovascular · 28d
Cleared Sep 13, 2002
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
K022738 · DQY
Guidant Corp.
Cardiovascular · 25d
Cleared Sep 13, 2002
GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500
K022880 · DXC
Guidant Corp.
Cardiovascular · 14d
Cleared Sep 11, 2002
JOSTRA VENT CATHETERS, MODELS LV & HKV
K022022 · DWF
Jostra AG
Cardiovascular · 83d
Cleared Sep 06, 2002
X-SCRIBE II
K022618 · DPS
Mortara Instrument, Inc.
Cardiovascular · 30d
Cleared Sep 05, 2002
AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100
K020693 · DWF
Embol-X, Inc.
Cardiovascular · 185d
Cleared Sep 04, 2002
QUINTON Q-CATH, MODEL 000460
K021906 · DQK
Quinton, Inc.
Cardiovascular · 86d
Cleared Sep 04, 2002
BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
K022621 · DQO
Boston Scientific Corp
Cardiovascular · 28d
Cleared Sep 03, 2002
MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC)
K022042 · DWF
Cardeon Corp.
Cardiovascular · 71d
Cleared Aug 28, 2002
PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
K020550 · DSI
Datascope Corp.
Cardiovascular · 190d
Cleared Aug 28, 2002
7F LAUNCHER GUIDE CATHETER
K022764 · DQY
Medtronic Vascular
Cardiovascular · 7d
Cleared Aug 26, 2002
LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2
K020529 · KFM
A-Med Systems, Inc.
Cardiovascular · 188d
Cleared Aug 23, 2002
3T VESSEL CANNULAS
K020768 · DWF
3t Medical Systems, LLC
Cardiovascular · 169d
Cleared Aug 23, 2002
BOLTON PTA CATHETER
K021996 · LIT
Bolton Medical, Inc.
Cardiovascular · 66d
Cleared Aug 23, 2002
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02
K022507 · MSX
Datex-Ohmeda
Cardiovascular · 24d
Cleared Aug 23, 2002
MODIFICATION TO MEDAMICUS AXIA RSN
K022689 · DYB
Medamicus, Inc.
Cardiovascular · 10d
Cleared Aug 21, 2002
COSMOS SYSTEM
K013046 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 345d
Cleared Aug 21, 2002
REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP
K021528 · JOW
Adven Medical
Cardiovascular · 103d
Cleared Aug 21, 2002
MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM
K022453 · DSI
Welch Allyn Protocol, Inc.
Cardiovascular · 26d
Cleared Aug 16, 2002
PALMO THERMOREGULATION INTERFACE ACCESSORY
K014210 · DWJ
Avacore Technologies, Inc.
Cardiovascular · 238d
Cleared Aug 15, 2002
TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM
K020537 · DXN
Tensys Medical, Inc.
Cardiovascular · 177d
Cleared Aug 15, 2002
AUTOPULSE RESUSCITATION SYSTEM
K022345 · DRM
Revivant Corp.
Cardiovascular · 27d
Cleared Aug 14, 2002
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K012523 · NLH
Sterilmed, Inc.
Cardiovascular · 373d
Cleared Aug 14, 2002
REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K012678 · NLH
Sterilmed, Inc.
Cardiovascular · 365d