ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J— 510(k) K062186
Substantially EquivalentAsahi Intecc Co., Ltd.
FDA 510(k) clearance K062186 for ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J, Substantially Equivalent on 2006-11-09. 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
- Special
- Location
- Newport Beach, CA, US
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.