PowerFlow Implantable Apheresis IV Port— 510(k) K191143

Name: FDA 510(k) clearance K191143
Creator: U.S. Food and Drug Administration
Published: 2019-08-02

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K191143 for PowerFlow Implantable Apheresis IV Port, Substantially Equivalent on 2019-08-02. Applicant: C.R. Bard, Inc.. Device class: 2.

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code PTD
Device class: Class 2
Regulation: 21 CFR 880.5965
Advisory panel: General Hospital
Date received: 2019-04-30
Decision date: 2019-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake Ciy,, UT, US

Download summary PDF View on FDA.gov ↗

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