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FDA 510(k)

AXS Offset Delivery Assist Catheter

K-Number: K163259 · 2017-07-28

Decision Date2017-07-28
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AXS Offset Delivery Assist Catheter is a medical device manufactured by Stryker Neurovascular. It received FDA 510(k) clearance on 2017-07-28 under approval number K163259. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXS Offset Delivery Assist Catheter?

AXS Offset Delivery Assist Catheter is a medical device that received FDA 510(k) clearance on 2017-07-28. It is manufactured by Stryker Neurovascular. The 510(k) number is K163259.

When was AXS Offset Delivery Assist Catheter approved by the FDA?

AXS Offset Delivery Assist Catheter received FDA 510(k) clearance on 2017-07-28, under approval number K163259.

What company makes AXS Offset Delivery Assist Catheter?

AXS Offset Delivery Assist Catheter is manufactured by Stryker Neurovascular.

What is the FDA product code for AXS Offset Delivery Assist Catheter?

The FDA product code for AXS Offset Delivery Assist Catheter is DQY.

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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.