510(k) K262165
K262165 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "FARADRIVE Steerable Sheath (M004PF21M402)". The FDA issued a decision of Substantially Equivalent on Jul 24, 2026. The device falls under product code DRA (Catheter, Steerable), a Class II device regulated under 21 CFR 870.1280. Boston Scientific Corporation has 238 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 24, 2026
- Date Received
- Jun 26, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Catheter, Steerable
- Device Class
- Class II
- Regulation Number
- 870.1280
- Review Panel
- CV
- Submission Type
- 510(k)