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FDA 510(k), K201806, Reprocessed PentaRay Nav eco High-Density Mapping Catheter
FDA 510(k), K201806, Reprocessed PentaRay Nav eco High-Density Mapping Catheter
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510(K) Number: K201806
Device Name: Reprocessed PentaRay Nav eco High-Density Mapping Catheter
Manufacturer: Sterilmed Inc. (Johnson and Johnson)
Device Classification Name: Catheter, Intracardiac Mapping, High-Density Array
Regulation Number: 870.1220
Classification Product Code: MTD
Date Received: 07/01/2020
Decision Date: 06/23/2021
Regulation Medical Specialty: Cardiovascular
Device Name: Reprocessed PentaRay Nav eco High-Density Mapping Catheter
Manufacturer: Sterilmed Inc. (Johnson and Johnson)
Device Classification Name: Catheter, Intracardiac Mapping, High-Density Array
Regulation Number: 870.1220
Classification Product Code: MTD
Date Received: 07/01/2020
Decision Date: 06/23/2021
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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