CYSTOGLIDE INTRODUCER SHEATH

Accessories, Catheter, G-u

PERCUTANEOUS SYSTEMS, INCORPORATED

The following data is part of a premarket notification filed by Percutaneous Systems, Incorporated with the FDA for Cystoglide Introducer Sheath.

Pre-market Notification Details

Device IDK052298
510k NumberK052298
Device Name:CYSTOGLIDE INTRODUCER SHEATH
ClassificationAccessories, Catheter, G-u
Applicant PERCUTANEOUS SYSTEMS, INCORPORATED 1300 CRITTENDEN LANE SUITE 101 Mountain View,  CA  94043 -1359
ContactThomas Lawson
CorrespondentThomas Lawson
PERCUTANEOUS SYSTEMS, INCORPORATED 1300 CRITTENDEN LANE SUITE 101 Mountain View,  CA  94043 -1359
Product CodeKNY  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-23
Decision Date2006-12-12
Summary:summary

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