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FDA 510(k)

MegaVac Mechanical Thrombectomy System

K-Number: K171493 · 2017-08-10

ApplicantCapture Vascular, Inc.
Decision Date2017-08-10
Product CodeQEX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MegaVac Mechanical Thrombectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Capture Vascular, Inc.. It received FDA 510(k) clearance on 2017-08-10 under 510(k) number K171493. The device is classified under product code QEX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MegaVac Mechanical Thrombectomy System?

MegaVac Mechanical Thrombectomy System is a medical device that received FDA 510(k) clearance on 2017-08-10. The listed applicant is Capture Vascular, Inc.. The 510(k) number is K171493.

When did MegaVac Mechanical Thrombectomy System receive FDA 510(k) clearance?

MegaVac Mechanical Thrombectomy System received FDA 510(k) clearance on 2017-08-10, under 510(k) number K171493.

Who is the listed applicant for MegaVac Mechanical Thrombectomy System?

The FDA 510(k) record lists Capture Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MegaVac Mechanical Thrombectomy System?

The FDA product code for MegaVac Mechanical Thrombectomy System is QEX.

Related Devices (Code: QEX)

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.

K253407NeVa PV Thrombectomy DeviceVesalio, Inc.K163618INDIGO Aspiration SystemPenumbra, Inc.

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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