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FDA 510(k), K220414, VersaCross Connect Transseptal Dilator
FDA 510(k), K220414, VersaCross Connect Transseptal Dilator
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510(K) Number: K220414
Device Name: VersaCross Connect Transseptal Dilator
Manufacturer: May Tsai
Device Classification Name: Introducer, Catheter
Regulation Number: DYB
Classification Product Code: 02/14/2022
Date Received: 05/09/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: VersaCross Connect Transseptal Dilator
Manufacturer: May Tsai
Device Classification Name: Introducer, Catheter
Regulation Number: DYB
Classification Product Code: 02/14/2022
Date Received: 05/09/2022
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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