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510(k) Data Aggregation
K Number
K191295Device Name
Percutaneous Introducer Needle
Manufacturer
Date Cleared
2019-08-06
(84 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Progressive Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Introducer for Endoscopic/Laparoscopic procedures.
Device Description
The PMIPIN15 Percutaneous Introducer Needle is a single- use, disposable EO sterilized device made of 304 stainless steel with a luer hub made of polycarbonate. The introducer sheath is 5 Fr and manufactured from low density polyethylene. The device is manually inserted by the physician during endoscopic and/or laparoscopic procedures.
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