# K150527: Xcela Power Injectable PICC

- Pathway: 510(k) (Special)
- Applicant: Navilyst Medical, Inc.
- Decided: Mar 31, 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K001901 (2000). 46 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070002: Boston Scientific Peripherally Inserted Central Catheter, Boston Scientific (2007) Summary page 4.
- K133264: Nmi Picc Iii, Navilyst Medical, Inc. (2013) Summary page 4.

## Most influential descendants
- K152409: Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC (2015), 0 descendants of its own

## 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 - 4 mL/sec 4F Single Lumen, 55 cm - 3.5 mL/sec 5F Single Lumen, 55 cm - 5 mL/sec 5F Dual Lumen, 45 ¢m - 5 mL/sec 5F Dual Lumen, 55 cm - 4 mL/sec 6F Dual Lumen, 55 cm - 5 mL/sec

Source page: https://510kreport.com/device/K150527
Methodology: https://510kreport.com/methodology