VIEWFLEX XTRA ICE CATHETER— 510(k) K133853
Substantially EquivalentIrvine Biomedical, Inc., A St. Jude Medical Company
FDA 510(k) clearance K133853 for VIEWFLEX XTRA ICE CATHETER, Substantially Equivalent on 2014-05-19. Applicant: Irvine Biomedical, Inc., A St. Jude Medical Company.
Clearance details
- Applicant
- Irvine Biomedical, Inc., A St. Jude Medical Company
- Product code
- Code OBJ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Adverse events under product code OBJ
product code OBJ- Death
- 38
- Injury
- 634
- Malfunction
- 3,453
- Total
- 4,125
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.