Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D— 510(k) K160335
Substantially EquivalentSt Jude Medical
FDA 510(k) clearance K160335 for Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D, Substantially Equivalent on 2016-12-13. Applicant: St Jude Medical.
Clearance details
- Applicant
- St Jude Medical
- Product code
- Code DRF
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Adverse events under product code DRF
product code DRF- Death
- 127
- Injury
- 1,676
- Malfunction
- 2,003
- Other
- 1
- Total
- 3,807
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.