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510(k) Data Aggregation
K Number
K191195Device Name
PiccGuard
Manufacturer
Date Cleared
2020-01-03
(245 days)
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
PiccGuard LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PICCGuard device is indicated for use as a tamper evident enclosure for the catheter and Luer hub with needleless connector attached on medical devices such as PICC lines and other central line catheter ports.
Device Description
The PICCGuard is a two-piece plastic housing with locking barb that inserts through a hole in the bottom housing. After inserting the shaft of the catheter and Luer hub with needleless connector attached, the two halves slide together, and the barb is pushed through the hole in the bottom housing. Once the barb is inserted, the housing is locked. When a healthcare provider needs intravenous access, medical scissors can be used to disconnect the lid from the locked portion. The PICCGuard is then removed giving access to the needleless connector, and the health care provider can administer medications per normal routine.
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