Atlas FDA

FARADRIVE™ Steerable Sheath

FDA 510(k) clearance K233248 · decided 2023-12-11

Clearance details

K-number
K233248
Device name
FARADRIVE™ Steerable Sheath
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2023-09-28
Decision date
2023-12-11
Days to decision
74 days
Clearance type
Traditional
Product code
DRA
Device class
2
Regulation number
870.1280
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
St Paul, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
FARADRIVE™ Steerable Sheath (M004PF21M402) (K262165)Boston Scientific Corporation2026-07-24
Globe Introducer (601-01001) (K250529)Kardium, Inc.2025-06-03
FlexCath Contour™ Steerable Sheath (K232321)Medtronic, Inc.2023-10-31
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 Corporation2023-03-22
MitraClip G4 Steerable Guide Catheter (K221397)ABBOTT MEDICAL2022-09-28
AcQGuide® VUE Steerable Sheath (K221044)Acutus Medical, Inc.2022-05-05
AcQGuide MAX Steerable Sheath (K211100)Acutus Medical, Inc.2021-05-14
FlexCath Advance Steerable Sheath and Dilator (K202620)Medtronic Cryocath, LP2020-11-13
Steerable Introducer 12F (K192422)Freudenberg Medical, LLC2019-10-04
MitraClip G4 Steerable Guide Catheter (K190167)Abbott2019-05-29
FlexCath Advance Steerable Sheath and Dilator (K183174)Medtronic Cryocath, LP2018-11-26
Steerable Guide Catheter (K172394)Abbott Vascular2017-09-06

Recalls involving this device

RecordFirmDate
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into th recall (Z-2755-2026)Boston Scientific Corporation2026-07-20
FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and recall (Z-2756-2026)Boston Scientific Corporation2026-07-20
FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and int recall (Z-2757-2026)Boston Scientific Corporation2026-07-20

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A209 SICD Gen 2,A219 SICD MRI (P110042/S206)Boston Scientific Corporation2025-10-22