# K163001: PowerFlow Apheresis I.V. Port

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Apr 17, 2017 after 171 days
- Product code: PTD (Subcutaneous Implanted Apheresis Port)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K926139 (1995). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926139: Cathlink 20 Titanium Port W/Att. Polyurethane Cath, Bard Access Systems, Inc. (1995) Summary page 4.

## Most influential descendants
- K192291: TidalPort-AP Implantable Apheresis Vascular Access Port (2020), 0 descendants of its own
- K191143: PowerFlow Implantable Apheresis IV Port (2019), 0 descendants of its own

## Recalls of this device
- Oct 1, 2019 · Class II · Z-1579-2020: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This ca

## Indications for use
The Bard PowerFlow™ Implantable Apheresis IV Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for long-term therapeutic apheresis, withdrawal of blood, and infusion of medications, I.V. fluids, parenteral nutrition solutions, blood and blood products. The Bard PowerFlow™ Implantable Apheresis IV Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.

Source page: https://510kreport.com/device/K163001
Methodology: https://510kreport.com/methodology