FDA 510(k)

FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)

K-Number: K240460 · 2024-06-13

Decision Date2024-06-13

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) is a medical device manufactured by FMD Co., Ltd.. It received FDA 510(k) clearance on 2024-06-13 under approval number K240460. 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 Wire F-18 Flex 400 (CSU415400259)?

FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) is a medical device that received FDA 510(k) clearance on 2024-06-13. It is manufactured by FMD Co., Ltd.. The 510(k) number is K240460.

When was FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) approved by the FDA?

FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) received FDA 510(k) clearance on 2024-06-13, under approval number K240460.

What company makes FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)?

FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) is manufactured by FMD Co., Ltd..

What is the FDA product code for FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)?

The FDA product code for FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) is DQX.

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Other Devices by FMD Co., Ltd.

K212268FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT 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

Related Devices (Code: DQX)

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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.