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FDA 510(k)

AXS Infinity LS Plus Long Sheath

K-Number: K193034 · 2019-11-29

ApplicantStryker Neurovascular
Decision Date2019-11-29
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AXS Infinity LS Plus Long Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Neurovascular. It received FDA 510(k) clearance on 2019-11-29 under 510(k) number K193034. 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 Infinity LS Plus Long Sheath?

AXS Infinity LS Plus Long Sheath is a medical device that received FDA 510(k) clearance on 2019-11-29. The listed applicant is Stryker Neurovascular. The 510(k) number is K193034.

When did AXS Infinity LS Plus Long Sheath receive FDA 510(k) clearance?

AXS Infinity LS Plus Long Sheath received FDA 510(k) clearance on 2019-11-29, under 510(k) number K193034.

Who is the listed applicant for AXS Infinity LS Plus Long Sheath?

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

What is the FDA product code for AXS Infinity LS Plus Long Sheath?

The FDA product code for AXS Infinity LS Plus Long Sheath is DQY.

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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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