FDA 510(k)

FARADRIVE™ Steerable Sheath (M004PF21M402)

Número K: K262165 · 2026-07-24

Data da decisão2026-07-24

Código do produtoDRA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Boston Scientific Corporation como candidato(a)

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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.

Fonte oficial

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