# K243941: HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire  - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire  - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204)

- Pathway: 510(k) (Special)
- Applicant: Access Vascular, Inc.
- Decided: Jan 17, 2025 after 28 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: 12 generations back to K001901 (2000). 44 ancestors in all.
No later device cites it as a predicate yet.
2 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193015: HydroPICC (PICC-142), Access Vascular, Inc. (2020) Summary page 5.

## Indications for use
HydroPICC Single Lumen: 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; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.Oml/s

Source page: https://510kreport.com/device/K243941
Methodology: https://510kreport.com/methodology