FDA 510(k) K232730, Aventus Thrombectomy System, by Inquis Medical
FDA 510(k) K232730, Aventus Thrombectomy System, by Inquis Medical
Device Classification Name: Peripheral Mechanical Thrombectomy With Aspiration
510(k) Number: K232730
Device Name: Aventus Thrombectomy System
Applicant: Inquis Medical
Regulation Number: 870.5150
Classification Product Code: QEW
Date Received: 09/07/2023
Decision Date: 11/01/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
510k Review Panel: Cardiovascular
Total number of pages: 1,544
Fully redacted pages: 1,377
Content pages: 167
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