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FDA 510(k)

AXS Offset Delivery Assist Catheter

K-Number: K163259 · 2017-07-28

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

Device Summary

AXS Offset Delivery Assist Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Neurovascular. It received FDA 510(k) clearance on 2017-07-28 under 510(k) 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. The listed applicant is Stryker Neurovascular. The 510(k) number is K163259.

When did AXS Offset Delivery Assist Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for AXS Offset Delivery Assist Catheter?

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 Offset Delivery Assist Catheter?

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

Related Clinical Trials

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NCT04195568Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter SystemACTIVE_NOT_RECRUITING

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Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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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