POWERPORT IMPLANTABLE PORT

Port & Catheter, Implanted, Subcutaneous, Intravascular

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Powerport Implantable Port.

Pre-market Notification Details

Device IDK133335
510k NumberK133335
Device Name:POWERPORT IMPLANTABLE PORT
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant C.R. BARD, INC. 605 N 5600 W Salt Lake City,  UT  84116
ContactAmy Honey
CorrespondentAmy Honey
C.R. BARD, INC. 605 N 5600 W Salt Lake City,  UT  84116
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-29
Decision Date2014-02-14
Summary:summary

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