MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER— 510(k) K933020

Name: FDA 510(k) clearance K933020
Creator: U.S. Food and Drug Administration
Published: 1994-01-03

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K933020 for MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER, Substantially Equivalent on 1994-01-03. Applicant: Boston Scientific Corp. Device class: 2.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code EYB
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1993-06-22
Decision date: 1994-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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