AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016— 510(k) K071125
Substantially EquivalentAga Medical Corp.
FDA 510(k) clearance K071125 for AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016, Substantially Equivalent on 2007-06-18. Applicant: Aga Medical Corp..
Clearance details
- Applicant
- Aga Medical Corp.
- Product code
- Code KRD
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Plymouth, MN, US
Adverse events under product code KRD
product code KRD- Death
- 119
- Injury
- 1,869
- Malfunction
- 7,015
- Other
- 1
- Total
- 9,004
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.