PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300— 510(k) K140466
Substantially EquivalentSt. Jude Medical Systems AB
FDA 510(k) clearance K140466 for PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300, Substantially Equivalent on 2014-11-13. Applicant: St. Jude Medical Systems AB.
Clearance details
- Applicant
- St. Jude Medical Systems AB
- Product code
- Code DXO
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Uppsala, SE
Adverse events under product code DXO
product code DXO- Death
- 10
- Injury
- 156
- Malfunction
- 884
- Total
- 1,050
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.