MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER— 510(k) K931619

Name: FDA 510(k) clearance K931619
Creator: U.S. Food and Drug Administration
Published: 1993-08-20

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K931619 for MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER, Substantially Equivalent on 1993-08-20. Applicant: Boston Scientific Corp. Device class: 2.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code GCA
Device class: Class 2
Regulation: 21 CFR 876.5010
Advisory panel: Gastroenterology, Urology
Date received: 1993-04-02
Decision date: 1993-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.