ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM— 510(k) K141218
Substantially EquivalentVadiswire Corporation
FDA 510(k) clearance K141218 for ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM, Substantially Equivalent on 2014-12-18. Applicant: Vadiswire Corporation.
Clearance details
- Applicant
- Vadiswire Corporation
- Product code
- Code DQX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kirkland, WA, 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.