FDA 510(k)

FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT

K-Number: K212268 · 2022-05-27

Decision Date2022-05-27

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT is a medical device manufactured by FMD Co., Ltd.. It received FDA 510(k) clearance on 2022-05-27 under approval number K212268. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT?

FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT is a medical device that received FDA 510(k) clearance on 2022-05-27. It is manufactured by FMD Co., Ltd.. The 510(k) number is K212268.

When was FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT approved by the FDA?

FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT received FDA 510(k) clearance on 2022-05-27, under approval number K212268.

What company makes FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT?

FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT is manufactured by FMD Co., Ltd..

What is the FDA product code for FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT?

The FDA product code for FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT is DQX.

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Other Devices by FMD Co., Ltd.

K240460FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) 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 40

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Official Source

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