FDA 510(k)

Aspirex™ Thrombectomy System

K-Number: K230356 · 2023-03-31

Decision Date2023-03-31

Product CodeQEW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Aspirex™ Thrombectomy System is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2023-03-31 under 510(k) number K230356. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aspirex™ Thrombectomy System?

Aspirex™ Thrombectomy System is a medical device that received FDA 510(k) clearance on 2023-03-31. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K230356.

When did Aspirex™ Thrombectomy System receive FDA 510(k) clearance?

Aspirex™ Thrombectomy System received FDA 510(k) clearance on 2023-03-31, under 510(k) number K230356.

Who is the listed applicant for Aspirex™ Thrombectomy System?

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

What is the FDA product code for Aspirex™ Thrombectomy System?

The FDA product code for Aspirex™ Thrombectomy System is QEW.

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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.