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CVC Wand Safety Introducer with Valved Peelable Sheath

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131148

by Access Scientific, Llc

Identifiers

510(k) Number
K131148 FDA 510(k)
FDA Product Code
DYB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1340 FDA 510(k)
Regulation Number
870.1340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CVC Wand Safety Introducer with Valved Peelable Sheath is a preassembled intravascular catheter introducer used by clinicians to facilitate the Seldinger Technique. It consists of a 21-gauge echogenic microaccess needle, Nitinol guidewire, nylon tissue dilator, and FEP peelable sheath with a valve. The device is indicated for use in percutaneous insertion of catheters into the venous system.

The CVC Wand Safety Introducer with Valved Peelable Sheath is supplied as a single-use device and is not intended for reuse. It is designed for use in clinical settings where central venous catheterization is performed. The device was cleared through the FDA 510k pathway with product code DYB and authorization number K131148.

Frequently asked questions

What is the CVC Wand Safety Introducer used for?

The CVC Wand Safety Introducer is a preassembled device used by clinicians to facilitate the Seldinger Technique for percutaneous insertion of catheters into the venous system. It includes a 21-gauge echogenic microaccess needle, Nitinol guidewire, nylon tissue dilator, and FEP peelable sheath with a valve.

Is the CVC Wand Safety Introduster reusable or single-use?

The CVC Wand Safety Introducer is supplied as a single-use device and is not intended for reuse. This design helps maintain sterility and reduces the risk of cross-contamination between patients.

What components are included in the CVC Wand Safety Introducer kit?

The device comes preassembled with a 21-gauge echogenic microaccess needle, Nitinol guidewire, nylon tissue dilator, and an FEP peelable sheath with a valve. These components work together to facilitate central venous catheterization using the Seldinger Technique.

What is the regulatory status of the CVC Wand Safety Introducer?

The CVC Wand Safety Introducer with Valved Peelable Sheath was cleared through the FDA 510k pathway with product code DYB and authorization number K131148. It received a decision of 'Substantially Equivalent' from the Cardiovascular advisory committee.

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: The CVC WAND Safety Introducer with Valved Peelable Sheath (K182243 ..., The Cvc Wand Safety Introducer With Valved Peelable Sheath, the cvc wand safety introducer with valved peelable sheath

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Access Scientific, Llc

Sources (1)

  • FDA 510(k) K131148 24 fields · synced Oct 6, 2026