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Ven-A-Cath Percutaneous Venous Catheter Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K881504

by Hdc Corp.

Identifiers

510(k) Number
K881504 FDA 510(k)
FDA Product Code
DQY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1250 FDA 510(k)
Regulation Number
870.1250 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Ven-A-Cath Percutaneous Venous Catheter Kit is a percutaneous venous catheter system intended for venous access, including central venous catheterization. It provides the components necessary to introduce a catheter into a vein for diagnostic or therapeutic purposes.

The kit is cleared by the FDA under 510(k) number K881504 as a Class 2 device (product code DQY). It is supplied as a complete kit for percutaneous insertion and is identified as a single-use medical device in the FDA submission.

Frequently asked questions

What clinical purpose does the VEN-A-CATH Percutaneous Venous Catheter Kit serve?

The kit is designed to obtain venous access, including central venous catheterization, allowing clinicians to insert a catheter for diagnostic sampling or therapeutic delivery. Its percutaneous system enables placement directly through the skin into a vein, which is essential for many inpatient procedures.

How is the VEN-A-CATH kit supplied and is it intended for reuse?

The device is supplied as a complete, ready‑to‑use kit containing all necessary components for percutaneous insertion. The FDA submission identifies it as a single‑use medical device, meaning each kit is intended to be used on one patient only and then discarded to maintain sterility and performance.

What regulatory clearance does the VEN-A-CATH kit have?

The VEN-A-CATH Percutaneous Venous Catheter Kit was cleared by the FDA through the 510(k) pathway (K881504) as a Class 2 device with product code DQY. This clearance indicates the FDA found it substantially equivalent to a legally marketed predicate device, allowing it to be marketed in the United States.

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: Ven-a-cath Percutaneous Venous Catheter Kit - Hdc | FDA Evidence Review, Ven-a-cath Percutaneous Venous Catheter Kit, VEN-A-CATH PERCUTANEOUS VENOUS CATHETER KIT 510(k)… - FDA.report, PDF K881504 - Ven-a-cath Percutaneous Venous Catheter Kit, 510(k) Premarket Notification - accessdata.fda.gov

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hdc Corp.

Sources (1)

  • FDA 510(k) K881504 24 fields · synced Sep 24, 2026