# K101329: Synergy CT Picc

- Pathway: 510(k) (Traditional)
- Applicant: Health Line International Corporation
- Decided: Aug 19, 2010 after 99 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). 32 ancestors in all.
6 later devices descend from it; 4 cite it directly.
2 of 39 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 4.
- K051102: Omnipicc PI, Rita Medical Systems, Inc. (2005) Summary page 2.
- K062579: Omnipicc P.I., Rita Medical Systems, Inc. (2006) Summary page 4.
- K093309: Pro-Line CT (Basic Tray) Model MR28036101, Medcomp ( Medical Components) (2009) Summary page 2.

## Most influential descendants
- 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
- K192533: Health Line CT CVC (2019), 0 descendants of its own

## Indications for use
The SYNERGY' Tm CT P1CC is indicated for short or long term (less than or greater than 30 days) peripheral access to the central venous system for infusion, intravenous therapy, blood sampling and power injection of contrast media. All SYNERGY'Tm CT P1CC products have a maximum recommended infusion rating of Smi/sec.

Source page: https://510kreport.com/device/K101329
Methodology: https://510kreport.com/methodology