Powerwand Safety Introducer With Extended Dwell Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131300 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 Catheter is a vascular access device designed for percutaneous introduction of catheters into the circulatory system. It combines an introducer needle, nitinol guidewire, dilator, and an extended dwell catheter in a preassembled system, enabling rapid and secure vascular access for diagnostic or therapeutic procedures. The device incorporates a passive needle safety mechanism to reduce procedural risks. Its design adheres to the Seldinger technique, facilitating efficient catheter placement while minimizing complications.
This device is supplied as a sterile, single-use system and is intended for use in clinical settings such as hospitals or outpatient care. It is classified under FDA 510(k) clearance (K131300) and is intended for vascular access, blood sampling, intravenous fluid administration, and power injection of contrast media (up to 8 ml/sec at 325 psi). The 3Fr size is available, and proper storage requires adherence to manufacturer guidelines to maintain sterility. No MRI safety information is specified.
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 an Extended Dwell Catheter, 3Fr ..., Powerwand™ Extended Dwell Catheters | ICU Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131300 | Class II | Active |
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Manufacturer
- Manufacturer
- Access Scientific, Llc
Sources (1)
- FDA 510(k) K131300 24 fields · synced Sep 19, 2026