FARADRIVE Steerable Sheath (M004PF21M402)— 510(k) K262165
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K262165 for FARADRIVE Steerable Sheath (M004PF21M402), Substantially Equivalent on 2026-07-24. Applicant: Boston Scientific Corporation. Device class: 2.
Summary
Boston Scientific's FARADRIVE Steerable Sheath (M004PF21M402) is filed under DRA, steerable catheters. The record gives the catalog number but no dimensions.
Class II, 21 CFR 870.1280. Cardiovascular is both the classification panel and the review panel. It came in as a Special 510(k).
Boston Scientific filed from Saint Paul, Minnesota. The decision came 28 calendar days after FDA received it (June 26 to July 24, 2026).
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Product code DRA
- Device class
- Class 2
- Regulation
- 21 CFR 870.1280
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Saint Paul, MN, US
Recent devices under product code DRA
view all- K250529 — Globe Introducer (601-01001)
- K233248 — FARADRIVE Steerable Sheath
- K232321 — FlexCath Contour Steerable Sheath
- K223824 — POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE Pressure Sensor
- K221397 — MitraClip G4 Steerable Guide Catheter
More clearances from Boston Scientific Corporation
view allAdverse 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.