COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM— 510(k) K930348

Name: FDA 510(k) clearance K930348
Creator: U.S. Food and Drug Administration
Published: 1993-09-03

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K930348 for COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM, Substantially Equivalent on 1993-09-03. Applicant: Boston Scientific Corp. Device class: 2.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code FDX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1993-01-25
Decision date: 1993-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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