FARADRIVE Steerable Sheath— 510(k) K233248
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K233248 for FARADRIVE Steerable Sheath, Substantially Equivalent on 2023-12-11. Applicant: Boston Scientific Corporation.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code DRA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St Paul, MN, US
Adverse events under product code DRA
product code DRA- Death
- 156
- Injury
- 3,133
- Malfunction
- 6,266
- Total
- 9,555
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.