Home › ASAHI INTECC CO., LTD. › CHIKAI black
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
| 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.
