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FDA 510(k)

Marathon Flow Directed Micro Catheter

K-Number: K202318 · 2020-09-14

Decision Date2020-09-14
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Marathon Flow Directed Micro Catheter is a medical device manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2020-09-14 under approval number K202318. 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 Marathon Flow Directed Micro Catheter?

Marathon Flow Directed Micro Catheter is a medical device that received FDA 510(k) clearance on 2020-09-14. It is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K202318.

When was Marathon Flow Directed Micro Catheter approved by the FDA?

Marathon Flow Directed Micro Catheter received FDA 510(k) clearance on 2020-09-14, under approval number K202318.

What company makes Marathon Flow Directed Micro Catheter?

Marathon Flow Directed Micro Catheter is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular.

What is the FDA product code for Marathon Flow Directed Micro Catheter?

The FDA product code for Marathon Flow Directed Micro Catheter 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.