ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension— 510(k) K163426
Substantially EquivalentAsahi Intecc Co., Ltd.
FDA 510(k) clearance K163426 for ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension, Substantially Equivalent on 2017-04-03. Applicant: Asahi Intecc Co., Ltd..
Clearance details
- Applicant
- Asahi Intecc Co., Ltd.
- Product code
- Code DQX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hagoya-Shi, JP
Adverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.