FDA 510(k)

Accoat 가이드 와이어

K-번호: K253667 · 2026-07-14

결정일2026-07-14

제품 코드DQX

자문 위원회CV

결정Substantially Equivalent

기기 요약

Accoat Guide Wire is the device name listed in this FDA 510(k) record. The listed applicant is Sp Medical A/S. It received FDA 510(k) clearance on 2026-07-14 under 510(k) number K253667. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Accoat Guide Wire?

Accoat Guide Wire is a medical device that received FDA 510(k) clearance on 2026-07-14. The listed applicant is Sp Medical A/S. The 510(k) number is K253667.

When did Accoat Guide Wire receive FDA 510(k) clearance?

Accoat Guide Wire received FDA 510(k) clearance on 2026-07-14, under 510(k) number K253667.

Who is the listed applicant for Accoat Guide Wire?

The FDA 510(k) record lists Sp Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Accoat Guide Wire?

The FDA product code for Accoat Guide Wire is DQX.

관련 기기 (코드: DQX)

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.K253746Enroute 0.014'' Transcarotid GuidewireLake Region Medical

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기기 요약

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관련 임상시험

관련 기기 (코드: DQX)

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