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Powerwand Safety Introducer With Extended Dwell

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121748

by Access Scientific, Inc.

Identifiers

510(k) Number
K121748 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 Powerwand Safety Introducer With Extended Dwell is an all-in-one preassembled intravascular catheter introducer system. It utilizes the Accelerated Seldinger Technique to facilitate percutaneous placement of an in-dwelling catheter into the circulatory system for blood sampling and intravenous fluid administration. The device is also indicated for the power injection of contrast media at a rate of 5 ml/sec at up to 300 psi fluid pressure.

This system includes an introducer needle, nitinol guidewire, dilator, and an extended dwell catheter. It features a passive needle stick safety mechanism and is authorized under FDA 510(k) clearance K121748. Users should refer to the device labeling for specific storage and handling requirements.

Frequently asked questions

What is the primary function of the Powerwand Safety Introducer?

This device is an all-in-one preassembled system used to facilitate the percutaneous placement of an in-dwelling catheter into the circulatory system. It is specifically indicated for blood sampling, the administration of intravenous fluids, and the power injection of contrast media at rates up to 5 ml/sec at 300 psi.

What components are included in the Powerwand system?

The system is designed as a preassembled unit to streamline the insertion process. It includes an introducer needle, a nitinol guidewire, a dilator, and an extended dwell catheter, all integrated to support the Accelerated Seldinger Technique.

Does the device include features for clinician protection?

Yes, the system is equipped with a passive needle stick safety mechanism. This feature is integrated into the design to help reduce the risk of accidental needle sticks during the catheter placement procedure.

What is the regulatory status of this device?

The Powerwand Safety Introducer with Extended Dwell is authorized under FDA 510(k) clearance, specifically documented under K121748. This indicates the device has been reviewed and found substantially equivalent for its intended use.

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 Powerwand Safety Introducer With an Extended Dwell Catheter, The Powerwand Safety Introducer With and Extended Dwell (K121748) — Fda ..., K111417 FDA 510(k) - THE POWERWAND SAFETY INTRODUCER WITH AN...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Access Scientific, Inc.

Sources (1)

  • FDA 510(k) K121748 24 fields · synced Sep 27, 2026