PIVOT STEERABLE MICROCATHETER— 510(k) K050630
Substantially EquivalentBoston Scientific - Precision Vascular
FDA 510(k) clearance K050630 for PIVOT STEERABLE MICROCATHETER, Substantially Equivalent on 2005-03-22. Applicant: Boston Scientific - Precision Vascular.
Clearance details
- Applicant
- Boston Scientific - Precision Vascular
- Product code
- Code KRA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- West Valley City, UT, US
Adverse events under product code KRA
product code KRA- Death
- 234
- Injury
- 1,029
- Malfunction
- 3,012
- Other
- 2
- Total
- 4,277
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.