# K173956: Biowy PlCC Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Biowy Corporation
- Decided: May 21, 2018 after 144 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001901 (2000). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051672: Powerpicc, Bard Access Systems, Inc. (2005) Summary page 4.

## Most influential descendants
- K192246: Biowy PICC Catheter S Kit (2020), 0 descendants of its own

## Indications for use
The Biowy PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the Biowy catheter may not exceed 300psi.

Source page: https://510kreport.com/device/K173956
Methodology: https://510kreport.com/methodology