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 (K243458)
Description
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 by Access Vascular, Inc., an FDA 510(k) cleared general hospital device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243458
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. 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 (K243458) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220772 | HydroMID 4F Single Lumen Midline Catheter | Access Vascular, Inc. | 2022 |
| K213550 | HydroPICC 5F Dual Lumen Catheter | Access Vascular, Inc. | 2022 |
| K193015 | HydroPICC (PICC-142) | Access Vascular, Inc. | 2020 |
Trace the full predicate network for K243458
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.