FDA 510(k)

MAGIC Flow-Dependent Microcatheter

K-Number: K213435 · 2022-07-19

Decision Date2022-07-19

Product CodeKRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MAGIC Flow-Dependent Microcatheter is a medical device manufactured by Balt USA, LLC. It received FDA 510(k) clearance on 2022-07-19 under approval number K213435. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGIC Flow-Dependent Microcatheter?

MAGIC Flow-Dependent Microcatheter is a medical device that received FDA 510(k) clearance on 2022-07-19. It is manufactured by Balt USA, LLC. The 510(k) number is K213435.

When was MAGIC Flow-Dependent Microcatheter approved by the FDA?

MAGIC Flow-Dependent Microcatheter received FDA 510(k) clearance on 2022-07-19, under approval number K213435.

What company makes MAGIC Flow-Dependent Microcatheter?

MAGIC Flow-Dependent Microcatheter is manufactured by Balt USA, LLC.

What is the FDA product code for MAGIC Flow-Dependent Microcatheter?

The FDA product code for MAGIC Flow-Dependent Microcatheter is KRA.

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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.