PG Pro Microcatheter— 510(k) K192625
Substantially EquivalentMicroVention, Inc. A TERUMO Group Company
FDA 510(k) clearance K192625 for PG Pro Microcatheter, Substantially Equivalent on 2019-11-21. Applicant: MicroVention, Inc. A TERUMO Group Company.
Clearance details
- Applicant
- MicroVention, Inc. A TERUMO Group Company
- Product code
- Code DQY
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Aliso Viejo, CA, US
Adverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
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.