TITANIUM POWERPORT ISP IMPLANTED 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 Titanium Powerport Isp Implanted Port.

Pre-market Notification Details

Device IDK072215
510k NumberK072215
Device Name:TITANIUM POWERPORT ISP IMPLANTED PORT
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant C.R. BARD, INC. 605 N 5600 W Salt Lake City,  UT  84116
ContactSusan D Scott
CorrespondentSusan D Scott
C.R. BARD, INC. 605 N 5600 W Salt Lake City,  UT  84116
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-09
Decision Date2007-11-01
Summary:summary

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