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FDA 510(k), K220047, AcQCross Qx Integrated Transseptal Dilator/Needle
FDA 510(k), K220047, AcQCross Qx Integrated Transseptal Dilator/Needle
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$149.00 USD
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510(K) Number: K220047
Device Name: AcQCross Qx Integrated Transseptal Dilator/Needle
Manufacturer: Acutus Medical, Inc.
Device Classification Name: Introducer, Catheter
Regulation Number: 870.1340
Classification Product Code: DYB
Date Received: 01/05/2022
Decision Date: 02/08/2022
Regulation Medical Specialty: Cardiovascular
Device Name: AcQCross Qx Integrated Transseptal Dilator/Needle
Manufacturer: Acutus Medical, Inc.
Device Classification Name: Introducer, Catheter
Regulation Number: 870.1340
Classification Product Code: DYB
Date Received: 01/05/2022
Decision Date: 02/08/2022
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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