# K011860: KEYST0NE Medical Picc Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Keystone Medical
- Decided: Jun 27, 2001 after 13 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953811 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953811: Medcomp P-Cath, Medcomp (1996) Summary page 1.

## Indications for use
The devices are intended for use when central venous catheterization or intravenous therapy for the administration of fluids, medications and/or nutritional therapy is prescribed. The use of the device for these indications is less than 30 days.

Source page: https://510kreport.com/device/K011860
Methodology: https://510kreport.com/methodology