# K152409: Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC

- Pathway: 510(k) (Special)
- Applicant: Navilyst Medical, Inc.
- Decided: Sep 24, 2015 after 29 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: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K001901 (2000). 47 ancestors in all.
No later device cites it as a predicate yet.
2 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150527: Xcela Power Injectable PICC, Navilyst Medical, Inc. (2015) Summary page 4.
- K093366: Nmi Picc II, Navilyst Medical, Inc. (2009) Summary page 4.
- K111906: Xcela Hybrid Picc with Pasv Valve Technology, Navilyst Medical, Inc. (2011) Summary page 5.

## Recalls of this device
- May 10, 2018 · Class II · Z-2188-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2218-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2219-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2225-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2220-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2212-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

## Indications for use
The Xcela Power Injectable PICC 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. Maximum Power Injection Flow Rate 4F Single Lumen - 45 cm length 4 mL/sec 5F Dual Lumen - 45 ¢cm length 5 mL/sec 4F Single Lumen - 55 cm length 3.5 mL/sec 5F Dual Lumen - 55 cm length 4 mL/sec 5F Single Lumen - 55 cm length 5 mL/sec 6F Dual Lumen - 55 cm length 5 mL/sec The Xcela PICC with PASV 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. The Xcela Hybrid PICC with PASV Valve technology is indicated for short or long-term 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 is 6 mL/sec.

Source page: https://510kreport.com/device/K152409
Methodology: https://510kreport.com/methodology