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510(k) K191195

PiccGuard by Piccguard, LLC — Product Code PZW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 3, 2020
Date Received: May 3, 2019
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Catheter Access Cover, Tamper-Resistant
Device Class: Class II
Regulation Number: 880.5970
Review Panel: HO
Submission Type

A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter