# K110914: Triple Lumen PFM Picc

- Pathway: 510(k) (Traditional)
- Applicant: Pfm Medical, Inc.
- Decided: Sep 21, 2011 after 173 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: 10 generations back to K001901 (2000). 27 ancestors in all.
No later device cites it as a predicate yet.
2 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083873: Picc (CT Rated and Non-Rated), Pfm Medical, Inc. (2009) Summary page 2.
- K071875: V-Cath Poly Picc, Hdc Corp. (2007) Summary page 2.

## Indications for use
The Triple Lumen PFM PICC (CT Rated and Non-Rated) is indicated for short or long term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling and power injection of contrast media. The Triple Lumen PFM PICC has a maximum recommended infusion rating of 5 ml/sec. The primary line of the Triple Lumen PFM PICC is also indicated for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter of lumen of 20 gauge or larger be used.

Source page: https://510kreport.com/device/K110914
Methodology: https://510kreport.com/methodology