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CHIKAI black

ASAHI INTECC CO., LTD. · Model WAIN-CKI-200-BS · UDI-DI 04547327098243

MOF Prescription
10
510(k) clearances
657
Adverse events (15 deaths)
2
Recalls
33
Facilities

Recalls

DateFirmReason
2024-04-18Stryker NeurovascularStryker 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
2017-08-07Microvention, Inc.There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.

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Data 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.