FARADRIVE™ Steerable Sheath (M004PF21M402)
FDA 510(k) clearance K262165 · decided 2026-07-24
Clearance details
- K-number
- K262165
- Device name
- FARADRIVE™ Steerable Sheath (M004PF21M402)
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2026-06-26
- Decision date
- 2026-07-24
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- DRA
- Device class
- 2
- Regulation number
- 870.1280
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Saint Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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