CYSTOGLIDE INTRODUCER SHEATH— 510(k) K052298

Name: FDA 510(k) clearance K052298
Creator: U.S. Food and Drug Administration
Published: 2006-12-12

Substantially Equivalent

Percutaneous Systems, Incorporated

FDA 510(k) clearance K052298 for CYSTOGLIDE INTRODUCER SHEATH, Substantially Equivalent on 2006-12-12. Applicant: Percutaneous Systems, Incorporated. Device class: 2.

Clearance details

Applicant: Percutaneous Systems, Incorporated
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2005-08-23
Decision date: 2006-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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