# K083873: Picc (CT Rated and Non-Rated)

- Pathway: 510(k) (Traditional)
- Applicant: Pfm Medical, Inc.
- Decided: Mar 19, 2009 after 80 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001901 (2000). 26 ancestors in all.
8 later devices descend from it; 2 cite it directly.
2 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072391: PFM Picc, Pfm Medical, Inc. (2007) Summary page 1.
- K071875: V-Cath Poly Picc, Hdc Corp. (2007) Summary page 1.

## Most influential descendants
- K101329: Synergy CT Picc (2010), 6 descendants of its own
- K130034: Uni-Picc (2013), 2 descendants of its own
- K140270: Nexus Midline CT Catheter (2014), 1 descendant of its own
- K113622: Orion II CT CVC (2012), 1 descendant of its own
- K200263: Health Line CT Midline Catheter (2020), 0 descendants of its own

## Recalls of this device
- Oct 20, 2014 · Class II · Z-0563-2015: PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
- Oct 20, 2014 · Class II · Z-0565-2015: PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
- Oct 20, 2014 · Class II · Z-0564-2015: PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

## Indications for use
The PICC (CT Rated and Non-Rated) is indicated for short or long term peripheral access to the central venous system for infusion, intravenous therapy, and blood sampling. The CT rated PICC is also indicated for the power injection of contrast media. The CT rated PICC has a maximum recommended infusion rating of 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.

Source page: https://510kreport.com/device/K083873
Methodology: https://510kreport.com/methodology