SLIP UROLOGY INTRODUCER SHEATH

Accessories, Catheter, G-u

PERCUTANEOUS SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK040520
510k NumberK040520
Device Name:SLIP UROLOGY INTRODUCER SHEATH
ClassificationAccessories, Catheter, G-u
Applicant PERCUTANEOUS SYSTEMS, INC. 555 THIRTEENTH STREET, NW Washington,  DC  20004
ContactHoward M Holstein
CorrespondentHoward M Holstein
PERCUTANEOUS SYSTEMS, INC. 555 THIRTEENTH STREET, NW Washington,  DC  20004
Product CodeKNY  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-27
Decision Date2004-05-20
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.