Boston Scientific Corp - FDA 510(k) Cleared Devices

Cleared Aug 19, 2023

LUX-Dx II (M302)

K231328 · MXD

Cardiovascular · 103d

Cleared Jun 15, 2015

XXL Vascular Balloon Dilatation Catheter

K150303 · LIT

Cardiovascular · 129d

Cleared Jun 05, 2015

Chariot Guiding Sheath

K150186 · DYB

Cardiovascular · 129d

Cleared Sep 25, 2014

PTA BALLOON DILATATION CATHETER

K141150 · LIT

Cardiovascular · 143d

Cleared Sep 10, 2014

Direxion Torqueable Microcatheter

K142259 · KRA

Cardiovascular · 27d

Cleared Jul 22, 2014

EQUALIZER OCCLUSION BALLOON CATHETER

K140273 · MJN

Cardiovascular · 169d

Cleared Jun 06, 2014

V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM

K141185 · DQK

Cardiovascular · 30d

Cleared Apr 17, 2014

ENCORE 26 ADVANTAGE KIT

K140745 · MAV

Cardiovascular · 23d

Cleared Apr 16, 2014

TRUEPATH CTO DEVICE

K140288 · PDU

Cardiovascular · 70d

Cleared Apr 16, 2014

INSERTION TOOL

K140673 · DQX

Cardiovascular · 29d

Cleared Feb 28, 2014

GLADIATOR ELITE PTA BALLOON DILATATION CATHETER

K132810 · LIT

Cardiovascular · 172d

Cleared Dec 20, 2013

ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS

K133566 · MCW

Cardiovascular · 30d