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 a medical device manufactured by Stryker Neurovascular. It received FDA 510(k) clearance on 2019-11-29 under approval 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. It is manufactured by Stryker Neurovascular. The 510(k) number is K193034.
When was AXS Infinity LS Plus Long Sheath approved by the FDA?
AXS Infinity LS Plus Long Sheath received FDA 510(k) clearance on 2019-11-29, under approval number K193034.
What company makes AXS Infinity LS Plus Long Sheath?
AXS Infinity LS Plus Long Sheath is manufactured by Stryker Neurovascular.
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.