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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,027 results
11329–11352 of 18,027
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 24, 1993
OPTI-PLAST 5F PTA CATHETERS
K933483 · LIT
Vas-Cath, Inc.
Cardiovascular · 86d
Cleared Sep 23, 1993
CARDIAC THERAPHY SYSTEM SCP 900
K921666 · LDD
Ppg Hellige B.V.
Cardiovascular · 534d
Cleared Sep 23, 1993
MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L
K931411 · DTB
Medtronic Vascular
Cardiovascular · 188d
Cleared Sep 22, 1993
BIOSCOPE
K923406 · DPS
Biotronik, GmbH & Co.
Cardiovascular · 439d
Cleared Sep 22, 1993
HEMOSTASIS VALVE AND TUBING SET
K930194 · DYB
Opticon Medical, Inc.
Cardiovascular · 251d
Cleared Sep 22, 1993
ON-LINE ANALYSIS SYSTEM
K930639 · DQK
Softheart, Inc.
Cardiovascular · 225d
Cleared Sep 22, 1993
INTROPEEL
K930801 · DYB
Menlo Care, Inc.
Cardiovascular · 218d
Cleared Sep 22, 1993
INTROPEEL V
K931218 · DYB
Menlo Care, Inc.
Cardiovascular · 196d
Cleared Sep 21, 1993
THE SAMUELS RETROGRAD VALVULOTOME
K932009 · MGZ
Vascutech, Inc.
Cardiovascular · 151d
Cleared Sep 17, 1993
OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 9300
K925402 · DXN
Cas Medical Systems, Inc.
Cardiovascular · 329d
Cleared Sep 17, 1993
AVE ALLIANCE DILATATION CATHETER
K931384 · LIT
Applied Vascular Engineering, Inc.
Cardiovascular · 183d
Cleared Sep 13, 1993
SCD(R) CONTROLLER
K933259 · JOW
Kendall Healthcare Products Co....
Cardiovascular · 69d
Cleared Sep 10, 1993
GUIDING CATHETER HEMOSTASIS VALVE CAP
K933033 · DQY
Arrow Intl., Inc.
Cardiovascular · 80d
Cleared Sep 09, 1993
SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT
K915547 · KFM
3M Health Care, Sarns
Cardiovascular · 638d
Cleared Sep 09, 1993
SCIMED VIPER
K933183 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 71d
Cleared Sep 03, 1993
EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC
K924163 · DRF
Boston Scientific Corp
Cardiovascular · 380d
Cleared Sep 03, 1993
SPACELABS MEDICAL PATIENT MONITOR
K930095 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 238d
Cleared Sep 02, 1993
CAPIOX SX HOLLOW FIBER OXYGENATOR
K922799 · DTZ
Terumo Medical Corp.
Cardiovascular · 449d
Cleared Sep 01, 1993
3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE
K930312 · DRX
3M Health Care, Ltd.
Cardiovascular · 222d
Cleared Sep 01, 1993
CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE
K932788 · DWZ
Cordis Corp.
Cardiovascular · 84d
Cleared Sep 01, 1993
CARDIMA SEEKER AND STUBBIE GUIDEWIRES
K932801 · DQX
Cardima, Inc.
Cardiovascular · 84d
Cleared Aug 31, 1993
LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES
K931662 · DYB
Pace Medical
Cardiovascular · 148d
Cleared Aug 30, 1993
9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER
K926000 · DSP
Boston Scientific Corp
Cardiovascular · 276d
Cleared Aug 30, 1993
PERCUTANEOUS INTRODUCER FOR VENA CAVA FILTER SYST
K932921 · DTK
B. Braun Vena-Tech
Cardiovascular · 76d