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FDA 510(k)

FARADRIVE™ Steerable Sheath (M004PF21M402)

K-Number: K262165 · 2026-07-24

ApplicantBoston Scientific Corporation
Decision Date2026-07-24
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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Related Devices (Code: DRA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250529Globe Introducer (601-01001)Kardium, Inc.K233248FARADRIVE™ Steerable SheathBoston Scientific CorporationK232321FlexCath 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 CorporationK221397MitraClip G4 Steerable Guide CatheterABBOTT MEDICALK221044AcQGuide® VUE Steerable SheathAcutus Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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