OCCLUDER OCCLUSION BALLOON CATHETER— 510(k) K133750

Name: FDA 510(k) clearance K133750
Creator: U.S. Food and Drug Administration
Published: 2014-01-08

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K133750 for OCCLUDER OCCLUSION BALLOON CATHETER, Substantially Equivalent on 2014-01-08. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code EYB
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2013-12-09
Decision date: 2014-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

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