# K243458: HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr

- Pathway: 510(k) (Traditional)
- Applicant: Access Vascular, Inc.
- Decided: Aug 1, 2025 after 266 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). 71 ancestors in all.
No later device cites it as a predicate yet.
2 of 72 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 7.
- K213550: HydroPICC 5F Dual Lumen Catheter, Access Vascular, Inc. (2022) Summary page 7.
- K220772: HydroMID 4F Single Lumen Midline Catheter, Access Vascular, Inc. (2022) Summary page 7.

## 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 5.0 ml/s HydroPICC Dual 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 a maximum power injection flow rate of 5.0 ml/s HydroMID Single Lumen: Indicated for short term access(< 30 days) to the peripheral venous access system for intravenous therapy, including but not limited to, the administration of fluids, medications, and the sampling of blood and blood products. Maximum Power Injection Flow Rate: 4Fr Single Lumen, 20cm: 6 ml/sec The Hydro Catheter lines incorporate MIMIX® Technology, an anti-thrombogenic bulk hydrogel material, designed to minimize the risk of thrombus formation on device surfaces. In vitro studies have demonstrated that both the external surfaces and internal fluid pathw ays of the catheter effectively reduce thrombus accumulation and thrombotic occlusions. This reduction in thrombus accumulation is achieved due to the catheter's steric barrier. The clinical impact has not been evaluated in human clinical trials. This device is not intended for the treatment of existing vein thrombosis.

Source page: https://510kreport.com/device/K243458
Methodology: https://510kreport.com/methodology