Boston Scientific Corp - FDA 510(k) Cleared Devices
Recent clearances: IceSeed 1.5 CX Straight Needle (H7493968333170), LUX-Dx II (M302), WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
432
Total
411
Cleared
0
Denied
FDA 510(k) Regulatory Record - Boston Scientific Corp Cardiovascular ✕
179 devices
Cleared
Aug 19, 2023
LUX-Dx II (M302)
Cardiovascular
103d
Cleared
Jun 15, 2015
XXL Vascular Balloon Dilatation Catheter
Cardiovascular
129d
Cleared
Jun 05, 2015
Chariot Guiding Sheath
Cardiovascular
129d
Cleared
Sep 25, 2014
PTA BALLOON DILATATION CATHETER
Cardiovascular
143d
Cleared
Sep 10, 2014
Direxion Torqueable Microcatheter
Cardiovascular
27d
Cleared
Jul 22, 2014
EQUALIZER OCCLUSION BALLOON CATHETER
Cardiovascular
169d
Cleared
Jun 06, 2014
V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
Cardiovascular
30d
Cleared
Apr 17, 2014
ENCORE 26 ADVANTAGE KIT
Cardiovascular
23d
Cleared
Apr 16, 2014
TRUEPATH CTO DEVICE
Cardiovascular
70d
Cleared
Apr 16, 2014
INSERTION TOOL
Cardiovascular
29d
Cleared
Feb 28, 2014
GLADIATOR ELITE PTA BALLOON DILATATION CATHETER
Cardiovascular
172d
Cleared
Dec 20, 2013
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS
Cardiovascular
30d
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