FDA 510(k), K180111, ClearGuard HD Antimicrobial Barrier Cap
FDA 510(k), K180111, ClearGuard HD Antimicrobial Barrier Cap
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510(K) Number: K180111
Device Name: ClearGuard HD Antimicrobial Barrier Cap
Manufacturer: Pursuit Vascular, Inc.
Device Classification Name: hemodialysis catheter luer end cap
Regulation Number: 876.5540
Classification Product Code: PEH
Date Received: 01/16/2018
Decision Date: 05/25/2018
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: ClearGuard HD Antimicrobial Barrier Cap
Manufacturer: Pursuit Vascular, Inc.
Device Classification Name: hemodialysis catheter luer end cap
Regulation Number: 876.5540
Classification Product Code: PEH
Date Received: 01/16/2018
Decision Date: 05/25/2018
Regulation Medical Specialty: Gastroenterology/Urology
- 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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