VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS

Catheter, Suprapubic (and Accessories)

ANGIOMED U.S., INC.

The following data is part of a premarket notification filed by Angiomed U.s., Inc. with the FDA for Vesico Suprapubic Bladder Drainage & Exchange Sets.

Pre-market Notification Details

Device IDK863386
510k NumberK863386
Device Name:VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS
ClassificationCatheter, Suprapubic (and Accessories)
Applicant ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim,  CA  92807
ContactRichard P Mohr
CorrespondentRichard P Mohr
ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim,  CA  92807
Product CodeKOB  
CFR Regulation Number876.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-03
Decision Date1986-10-24

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