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V-Cath Poly Picc

FDA 510(k)

Class II (US FDA 510(k))

510(k) K071875

by Hdc Corp.

Identifiers

510(k) Number
K071875 FDA 510(k)
FDA Product Code
LJS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5970 FDA 510(k)
Regulation Number
880.5970 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

V-CATH POLY PICC is a catheter, intravascular, therapeutic, long-term greater than 30 days. It is a peripherally inserted central venous catheter made of radiopaque polyurethane tubing with a kink-resistant, reverse-tapered design.

It is used for repeated venous access, infusion, or injection therapy and supports power injection of contrast media up to 5 cc/sec at 300 psi. The device is supplied by Hdc Corp. and has FDA 510(k) clearance under K071875. It is classified as a Class 2 device for general hospital use.

Frequently asked questions

What is the V-CATH POLY PICC used for?

The V-CATH POLY PICC is used for repeated venous access, infusion, or injection therapy and supports power injection of contrast media up to 5 cc/sec at 300 psi, making it suitable for long-term intravenous treatment in general hospital settings.

How is the V-CATH POLY PICC supplied and what materials is it made from?

The V-CATH POLY PICC is supplied by Hdc Corp. and is constructed from radiopaque polyurethane tubing with a kink-resistant, reverse-tapered design to maintain patency and resist occlusion during long-term use.

Is the V-CATH POLY PICC intended for single use or reuse?

As a long-term peripherally inserted central venous catheter designed for use greater than 30 days, the V-CATH POLY PICC is intended for dwell time exceeding 30 days and is not a single-use device; it remains in place for extended therapy under clinical supervision.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: V-CATH POLY PICC (K071875) — FDA 510 (k) | Innolitics, K033853 FDA 510 (k) - MODIFICATION TO V-CATH POLY PICC, PDF 510(k) Summary - Food and Drug Administration, K964966 FDA 510 (k) - V-CATH | Hdc Corp.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hdc Corp.

Sources (1)

  • FDA 510(k) K071875 24 fields · synced Sep 28, 2026