# K171994: Silicone Peripherally Inserted Central Venous Catheter Set/Tray

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Feb 22, 2018 after 234 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: 3 generations back to K862056 (1986). 9 ancestors in all.
No later device cites it as a predicate yet.
2 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030270: 3F X 60 CM Single Lumen Silisone Vascu-Picc, 4F X 60CM Single Lumen Silicone Vascu-Picc, 5F X 60 CM Single Lumen Silicon, Medcomp (2003) Summary page 4.
- K021557: Spectrum Silicone Catheter, Cook, Inc. (2003) Summary page 4.

## Indications for use
The Silicone Peripherally Inserted Central Venous Catheter Set/Tray is intended for delivery of whole blood or blood products, drug administration and blood sampling.

Source page: https://510kreport.com/device/K171994
Methodology: https://510kreport.com/methodology