FDA 510(k)

FARADRIVE™ Steerable Sheath (M004PF21M402)

K-번호: K262165 · 2026-07-24

결정일2026-07-24

제품 코드DRA

자문 위원회CV

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Boston Scientific Corporation를 신청인으로 등재한 기타 기록

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