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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 the device name listed in this FDA 510(k) record. The listed applicant is Imds Operations B.V.. It received FDA 510(k) clearance on 2025-04-17 under 510(k) 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. The listed applicant is Imds Operations B.V.. The 510(k) number is K242337.

When did FlowGuide (FG60F); GuidionShort (GS60F) receive FDA 510(k) clearance?

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

Who is the listed applicant for FlowGuide (FG60F); GuidionShort (GS60F)?

The FDA 510(k) record lists Imds Operations B.V. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Imds Operations B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241611ShapeIT (SI014135)K223728Micro RxK210431ReCrossK210110GuidionK200324NHancer RxK191229TrapIt

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Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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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