FDA 510(k)

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

K-Number: K220258 · 2022-07-14

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 a medical device manufactured by Avia Vascular. It received FDA 510(k) clearance on 2022-07-14 under approval 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. It is manufactured by Avia Vascular. The 510(k) number is K220258.

When was 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) approved by the FDA?

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

What company makes 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 manufactured by Avia Vascular.

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.

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Official Source

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