K260544

FMD 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 40

510(k) number: K260544
Device name: FMD 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 40
Applicant: FMD Co., Ltd. JP
Product code: DQX — Wire, Guide, Catheter
Decision date: 2026-03-20
Date received: 2026-02-18
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: Cardiovascular

PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain

Also available from FDA: K260544.pdf

Official FDA record: K260544

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.