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FDA 510(k), K190785, Reprocessed PentaRay Nav eco High-Density Mapping Catheter
FDA 510(k), K190785, Reprocessed PentaRay Nav eco High-Density Mapping Catheter
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$149.00 USD
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510(K) Number: K190785
Device Name: Reprocessed PentaRay Nav eco High-Density Mapping Catheter
Manufacturer: Amanda Babcock
Device Classification Name: Catheter, Intracardiac Mapping, High-Density, Reprocessed
Regulation Number: NLG
Classification Product Code: 03/27/2019
Date Received: 06/25/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Reprocessed PentaRay Nav eco High-Density Mapping Catheter
Manufacturer: Amanda Babcock
Device Classification Name: Catheter, Intracardiac Mapping, High-Density, Reprocessed
Regulation Number: NLG
Classification Product Code: 03/27/2019
Date Received: 06/25/2019
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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