CYSTOGLIDE DILATING INTRODUCER SHEATH— 510(k) K052134

Name: FDA 510(k) clearance K052134
Creator: U.S. Food and Drug Administration
Published: 2005-09-22

Substantially Equivalent

Percutaneous Systems, Inc.

FDA 510(k) clearance K052134 for CYSTOGLIDE DILATING INTRODUCER SHEATH, Substantially Equivalent on 2005-09-22. Applicant: Percutaneous Systems, Inc.. Device class: 2.

Clearance details

Applicant: Percutaneous Systems, Inc.
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2005-08-05
Decision date: 2005-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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