PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300— 510(k) K133587
Substantially EquivalentSt. Jude Medical Systems AB
FDA 510(k) clearance K133587 for PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300, Substantially Equivalent on 2013-12-20. Applicant: St. Jude Medical Systems AB.
Clearance details
- Applicant
- St. Jude Medical Systems AB
- Product code
- Code DRG
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Westford, MA, US
Adverse events under product code DRG
product code DRG- Death
- 5
- Total
- 5
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.