Cleared Traditional

FARADRIVE? Steerable Sheath

K233248 · Boston Scientific Corporation · Cardiovascular
Dec 2023
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K233248 is an FDA 510(k) clearance for the FARADRIVE? Steerable Sheath, a Catheter, Steerable (Class II — Special Controls, product code DRA), submitted by Boston Scientific Corporation (Alternate Contact, US). The FDA issued a Cleared decision on December 11, 2023, 74 days after receiving the submission on September 28, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1280.

Submission Details

510(k) Number K233248 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2023
Decision Date December 11, 2023
Days to Decision 74 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRA — Catheter, Steerable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1280

Similar Devices — DRA Catheter, Steerable

All 40
Globe Introducer (601-01001)
K250529 · Kardium, Inc. · Jun 2025
FlexCath Contour? Steerable Sheath
K232321 · Medtronic, Inc. · Oct 2023
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
K223824 · Boston Scientific Corporation · Mar 2023
MitraClip G4 Steerable Guide Catheter
K221397 · Abbott Medical · Sep 2022
AcQGuide? VUE Steerable Sheath
K221044 · Acutus Medical, Inc. · May 2022
AcQGuide MAX Steerable Sheath
K211100 · Acutus Medical, Inc. · May 2021