FDA 510(k)

FARADRIVE™ Steerable Sheath (M004PF21M402)

N.º K: K262165 · 2026-07-24

SolicitanteBoston Scientific Corporation

Fecha de decisión2026-07-24

Código de productoDRA

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

FARADRIVE™ Steerable Sheath (M004PF21M402) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2026-07-24 under 510(k) number K262165. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the FARADRIVE™ Steerable Sheath (M004PF21M402)?

FARADRIVE™ Steerable Sheath (M004PF21M402) is a medical device that received FDA 510(k) clearance on 2026-07-24. The listed applicant is Boston Scientific Corporation. The 510(k) number is K262165.

When did FARADRIVE™ Steerable Sheath (M004PF21M402) receive FDA 510(k) clearance?

FARADRIVE™ Steerable Sheath (M004PF21M402) received FDA 510(k) clearance on 2026-07-24, under 510(k) number K262165.

Who is the listed applicant for FARADRIVE™ Steerable Sheath (M004PF21M402)?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FARADRIVE™ Steerable Sheath (M004PF21M402)?

The FDA product code for FARADRIVE™ Steerable Sheath (M004PF21M402) is DRA.

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Otros registros que enlistan a Boston Scientific Corporation como solicitante

K262151SpaceOAR Flex™ System K261153LithoVue Elite Digital Flexible Ureteroscope System K261915Navigator™ Flex Ureteral Access Sheath Set K262462TheraSphere 360™ Y-90 Management Platform K261488OBSIDIO Conformable Embolic K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System

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Dispositivos relacionados (Código: DRA)

K250529Globe Introducer (601-01001)Kardium, Inc.K233248FARADRIVE™ Steerable SheathBoston Scientific Corporation K232321FlexCath Contour™ Steerable SheathMedtronic, Inc.K223824POLARSHEATH™ 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 SensorBoston Scientific Corporation K221397MitraClip G4 Steerable Guide CatheterABBOTT MEDICAL K221044AcQGuide® VUE Steerable SheathAcutus Medical, Inc.

Fuente oficial

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