SelectFlex Neurovascular Access System Family— 510(k) K230322
Substantially EquivalentQ'Apel Medical, Inc.
FDA 510(k) clearance K230322 for SelectFlex Neurovascular Access System Family, Substantially Equivalent on 2023-06-22. Applicant: Q'Apel Medical, Inc..
Clearance details
- Applicant
- Q'Apel Medical, Inc.
- Product code
- Code QJP
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
Adverse events under product code QJP
product code QJP- Death
- 43
- Injury
- 233
- Malfunction
- 1,010
- Total
- 1,286
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.