FARADRIVE™ Steerable Sheath (M004PF21M402)
Device Facts
| Record ID | K262165 |
|---|---|
| Device Name | FARADRIVE™ Steerable Sheath (M004PF21M402) |
| Applicant | Boston Scientific Corporation |
| Product Code | DRA · Cardiovascular |
| Decision Date | Jul 24, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1280 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.
