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NEUROSCOUT
Cerenovus, Inc. · Model 601-314 · UDI-DI 10886704028376
1
510(k) clearances
670
Adverse events (15 deaths)
2
Recalls
34
Facilities
Description
NEUROSCOUT 14 STEERABLE GUIDEWIRES Guidewire Dia. .014 Inch (.36mm) Usable Length 205cm 10cm Steerable Guidewire with Hydrophilic Coating Tip Flexibility Standard Contents: 1 guidewire, 1 torquing device and 1 introducer.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-18 | Stryker Neurovascular | Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire |
| 2017-08-07 | Microvention, Inc. | There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.