ASPIRA PERITONEAL DRAINAGE SYSTEM

Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Aspira Peritoneal Drainage System.

Pre-market Notification Details

Device IDK081288
510k NumberK081288
Device Name:ASPIRA PERITONEAL DRAINAGE SYSTEM
ClassificationPeritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
Applicant C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City,  UT  84116
ContactHenry Boland
CorrespondentHenry Boland
C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City,  UT  84116
Product CodePNG  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-07
Decision Date2008-07-18
Summary:summary

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