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FDA 510(k), K180801, Actreen Hi-Lite Cath, Actreen Hi-Lite Set
FDA 510(k), K180801, Actreen Hi-Lite Cath, Actreen Hi-Lite Set
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$149.00 USD
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510(K) Number: K180801
Device Name: Actreen Hi-Lite Cath, Actreen Hi-Lite Set
Manufacturer: B. Braun Medical Inc.
Device Classification Name: catheter, urethral
Regulation Number: 876.5130
Classification Product Code: GBM
Date Received: 03/28/2018
Decision Date: 11/05/2018
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Actreen Hi-Lite Cath, Actreen Hi-Lite Set
Manufacturer: B. Braun Medical Inc.
Device Classification Name: catheter, urethral
Regulation Number: 876.5130
Classification Product Code: GBM
Date Received: 03/28/2018
Decision Date: 11/05/2018
Regulation Medical Specialty: Gastroenterology/Urology
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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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