Cronus Guidewire, Model 001-001470-1
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K051373 FDA 510(k)
- FDA Product Code
- NDQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1290 FDA 510(k)
- Regulation Number
- 870.1290 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cronus Guidewire is a steerable, magnetic guidewire intended for cardiovascular endovascular procedures. It has a nominal diameter of 0.014 in (0.36 mm) and is available in lengths of 210 cm or 300 cm, and is designed for use only with the Stereotaxis Telstar™ Magnetic Navigation System.
The device is classified as a Class II medical device (product code NDQ) and received FDA 510(k) clearance (K051373) on 9 December 2005 as substantially equivalent to a predicate device. It is supplied by Stereotaxis, Inc. in Saint Louis, MO, and is identified by model 001-001470-1.
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: CRONUS GUIDEWIRE, MODEL 001-001470-1 by STEREOTAXIS, INC. | FDA 510 (k ..., CRONUS GUIDEWIRE, MODEL 001-001470-1 (K051373) — FDA 510 (k ..., PDF K051373 - Cronus Guidewire, Model 001-001470-1, CRONUS GUIDEWIRE, MODEL 001-001470-1 510(k) K051373 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051373 | Class II | Active |
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Manufacturer
- Manufacturer
- Stereotaxis, Inc.
Sources (1)
- FDA 510(k) K051373 24 fields · synced Oct 1, 2026