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FDA 510(k), K191546, Epicardial Access System
FDA 510(k), K191546, Epicardial Access System
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510(K) Number: K191546
Device Name: Epicardial Access System
Manufacturer: May Tsai
Device Classification Name: Introducer, Catheter
Regulation Number: DYB
Classification Product Code: 06/12/2019
Date Received: 08/02/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Epicardial Access System
Manufacturer: May Tsai
Device Classification Name: Introducer, Catheter
Regulation Number: DYB
Classification Product Code: 06/12/2019
Date Received: 08/02/2019
Decision Date: Substantially Equivalent (SESE)
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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