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FDA 510(k)

FlowGuide (FG60F); GuidionShort (GS60F)

K-Number: K242337 · 2025-04-17

ApplicantImds Operations B.V.
Decision Date2025-04-17
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FlowGuide (FG60F); GuidionShort (GS60F) is a medical device manufactured by Imds Operations B.V.. It received FDA 510(k) clearance on 2025-04-17 under approval number K242337. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FlowGuide (FG60F); GuidionShort (GS60F)?

FlowGuide (FG60F); GuidionShort (GS60F) is a medical device that received FDA 510(k) clearance on 2025-04-17. It is manufactured by Imds Operations B.V.. The 510(k) number is K242337.

When was FlowGuide (FG60F); GuidionShort (GS60F) approved by the FDA?

FlowGuide (FG60F); GuidionShort (GS60F) received FDA 510(k) clearance on 2025-04-17, under approval number K242337.

What company makes FlowGuide (FG60F); GuidionShort (GS60F)?

FlowGuide (FG60F); GuidionShort (GS60F) is manufactured by Imds Operations B.V..

What is the FDA product code for FlowGuide (FG60F); GuidionShort (GS60F)?

The FDA product code for FlowGuide (FG60F); GuidionShort (GS60F) is DQY.

Other Devices by Imds Operations B.V.

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Official Source

View on FDA Database →

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

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