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FDA 510(k)

20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)

K-Number: K220258 · 2022-07-14

ApplicantAvia Vascular
Decision Date2022-07-14
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) is the device name listed in this FDA 510(k) record. The listed applicant is Avia Vascular. It received FDA 510(k) clearance on 2022-07-14 under 510(k) number K220258. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)?

20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) is a medical device that received FDA 510(k) clearance on 2022-07-14. The listed applicant is Avia Vascular. The 510(k) number is K220258.

When did 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) receive FDA 510(k) clearance?

20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) received FDA 510(k) clearance on 2022-07-14, under 510(k) number K220258.

Who is the listed applicant for 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)?

The FDA 510(k) record lists Avia Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)?

The FDA product code for 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) is JKA.

Related Devices (Code: JKA)

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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.

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