510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163001Substantially Equivalent

PowerFlow Apheresis I.V. Port

C.R. Bard Inc, Salt Lake Ciy, UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163001 is the FDA 510(k) clearance record for PowerFlow Apheresis I.V. Port, a class II device, cleared for C.R. Bard, Inc. on under FDA product code PTD (Subcutaneous Implanted Apheresis Port). FDA's definition for product code PTD reads: "A subcutaneous implanted apheresis port is a prescription device intended for patient therapies requiring repeated access to the vascular system and long-term therapeutic apheresis". FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show one recall naming K163001.

Clearance record

Decision date
Received
(171 days to decision)
Product code
PTD Subcutaneous Implanted Apheresis Port
Regulation
21 CFR 880.5965
Device class
Class II
Review panel
General Hospital
Applicant
C.R. Bard, Inc. 605 N. 5600 W., Salt Lake Ciy, UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PTD

Trailing 12 months

FDA records hold no clearances under product code PTD in the trailing twelve months.

FDA records show no clearances under product code PTD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PTD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260