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FDA 510(k)

Agile Devices Angler Steerable, Deflectable Microcatheter

K-Number: K211110 · 2022-01-07

ApplicantAgile Devices, Inc.
Decision Date2022-01-07
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Agile Devices Angler Steerable, Deflectable Microcatheter is a medical device manufactured by Agile Devices, Inc.. It received FDA 510(k) clearance on 2022-01-07 under approval number K211110. 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 Agile Devices Angler Steerable, Deflectable Microcatheter?

Agile Devices Angler Steerable, Deflectable Microcatheter is a medical device that received FDA 510(k) clearance on 2022-01-07. It is manufactured by Agile Devices, Inc.. The 510(k) number is K211110.

When was Agile Devices Angler Steerable, Deflectable Microcatheter approved by the FDA?

Agile Devices Angler Steerable, Deflectable Microcatheter received FDA 510(k) clearance on 2022-01-07, under approval number K211110.

What company makes Agile Devices Angler Steerable, Deflectable Microcatheter?

Agile Devices Angler Steerable, Deflectable Microcatheter is manufactured by Agile Devices, Inc..

What is the FDA product code for Agile Devices Angler Steerable, Deflectable Microcatheter?

The FDA product code for Agile Devices Angler Steerable, Deflectable 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.

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