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FDA 510(k)

AXS Vecta Aspiration System

K-Number: K191768 · 2019-07-30

ApplicantStryker Neurovascular
Decision Date2019-07-30
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AXS Vecta Aspiration System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Neurovascular. It received FDA 510(k) clearance on 2019-07-30 under 510(k) number K191768. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXS Vecta Aspiration System?

AXS Vecta Aspiration System is a medical device that received FDA 510(k) clearance on 2019-07-30. The listed applicant is Stryker Neurovascular. The 510(k) number is K191768.

When did AXS Vecta Aspiration System receive FDA 510(k) clearance?

AXS Vecta Aspiration System received FDA 510(k) clearance on 2019-07-30, under 510(k) number K191768.

Who is the listed applicant for AXS Vecta Aspiration System?

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 Vecta Aspiration System?

The FDA product code for AXS Vecta Aspiration System is NRY.

Related Clinical Trials

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Related Devices (Code: NRY)

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.

K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.K262399Millipede SystemPerfuze, Ltd.K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLCK260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited

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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