POLY PER-Q-CATH PICC CATHETERS; POLY RADPICC

Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Poly Per-q-cath Picc Catheters; Poly Radpicc.

Pre-market Notification Details

Device IDK031129
510k NumberK031129
Device Name:POLY PER-Q-CATH PICC CATHETERS; POLY RADPICC
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City,  UT  84116
ContactPeggy Keiffer
CorrespondentPeggy Keiffer
C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City,  UT  84116
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-09
Decision Date2003-05-05
Summary:summary

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