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FDA 510(k)

Cardio Flow Peripheral Guide Wire

K-Number: K213834 · 2022-03-18

Decision Date2022-03-18
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cardio Flow Peripheral Guide Wire is a medical device manufactured by Cardio Flow Inc.,. It received FDA 510(k) clearance on 2022-03-18 under approval number K213834. 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 Cardio Flow Peripheral Guide Wire?

Cardio Flow Peripheral Guide Wire is a medical device that received FDA 510(k) clearance on 2022-03-18. It is manufactured by Cardio Flow Inc.,. The 510(k) number is K213834.

When was Cardio Flow Peripheral Guide Wire approved by the FDA?

Cardio Flow Peripheral Guide Wire received FDA 510(k) clearance on 2022-03-18, under approval number K213834.

What company makes Cardio Flow Peripheral Guide Wire?

Cardio Flow Peripheral Guide Wire is manufactured by Cardio Flow Inc.,.

What is the FDA product code for Cardio Flow Peripheral Guide Wire?

The FDA product code for Cardio Flow Peripheral Guide Wire is DQX.

Related Clinical Trials

Other Devices by Cardio Flow Inc.,

Related Devices (Code: DQX)

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.