# K111906: Xcela Hybrid Picc with Pasv Valve Technology

- Pathway: 510(k) (Special)
- Applicant: Navilyst Medical, Inc.
- Decided: Jul 29, 2011 after 24 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: 9 generations back to K001901 (2000). 40 ancestors in all.
14 later devices descend from it; 4 cite it directly.
2 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101326: NMI IC, Navilyst Medical, Inc. (2010) Summary page 1.
- K091261: Nmi Picc, Navilyst Medical, Inc. (2009) Summary page 1.
- K093366: Nmi Picc II, Navilyst Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- K122882: Nmi Hpicc Iii (2012), 12 descendants of its own
- K131942: Nmi Picc Iii Catheter, Nmi Hpicc Iii Catheter (2013), 7 descendants of its own
- K133264: Nmi Picc Iii (2013), 6 descendants of its own
- K140266: Nmi Picc IV (2014), 3 descendants of its own
- K131038: Nmi Picc Maximal Barrier Nursing Kits (2013), 3 descendants of its own

## Indications for use
The XcelaTM Hybrid P1CC with PASVTM Valve Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the XcelaTM Hybrid P1CC with PASVTM Valve Technology is 6 niL/sec.

Source page: https://510kreport.com/device/K111906
Methodology: https://510kreport.com/methodology