20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)— 510(k) K220258
Substantially EquivalentAvia Vascular
FDA 510(k) clearance K220258 for 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000), Substantially Equivalent on 2022-07-14. Applicant: Avia Vascular.
Clearance details
- Applicant
- Avia Vascular
- Product code
- Code JKA
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Adverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
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.