FDA 510(k) K223914, ACTIV™ Cap, by Cleansite Medical, Inc.
FDA 510(k) K223914, ACTIV™ Cap, by Cleansite Medical, Inc.
Device Classification Name: Cap, Device Disinfectant
510(k) Number: K223914
Device Name: ACTIV™ Cap
Applicant: Cleansite Medical, Inc.
Regulation Number: 880.5440
Classification Product Code: QBP
Date Received: 12/29/2022
Decision Date: 04/05/2024
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
510k Review Panel: General Hospital
Total number of pages: 2,261
Fully redacted pages: 1,856
Content pages: 405
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