PowerFlow Apheresis I.V. Port

Subcutaneous Implanted Apheresis Port

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Powerflow Apheresis I.v. Port.

Pre-market Notification Details

Device IDK163001
510k NumberK163001
Device Name:PowerFlow Apheresis I.V. Port
ClassificationSubcutaneous Implanted Apheresis Port
Applicant C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City,  UT  84116
ContactChristoph Wagner Von Hoff
CorrespondentChristoph Wagner Von Hoff
C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City,  UT  84116
Product CodePTD  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-28
Decision Date2017-04-17
Summary:summary

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