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FDA 510(k)

Micro Rx

K-Number: K223728 · 2023-07-13

ApplicantImds Operations B.V.
Decision Date2023-07-13
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Micro Rx 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 2023-07-13 under 510(k) number K223728. 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 Micro Rx?

Micro Rx is a medical device that received FDA 510(k) clearance on 2023-07-13. The listed applicant is Imds Operations B.V.. The 510(k) number is K223728.

When did Micro Rx receive FDA 510(k) clearance?

Micro Rx received FDA 510(k) clearance on 2023-07-13, under 510(k) number K223728.

Who is the listed applicant for Micro Rx?

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 Micro Rx?

The FDA product code for Micro Rx 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.

K242337FlowGuide (FG60F); GuidionShort (GS60F)K241611ShapeIT (SI014135)K210431ReCrossK210110GuidionK200324NHancer 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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