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510(k) Data Aggregation
K Number
K230668Device Name
Disposable High-pressure Extension Lines
Manufacturer
Precision Medical Plastics Ltd.
Date Cleared
2024-06-14
(462 days)
Product Code
DXT
Regulation Number
870.1650Why did this record match?
Applicant Name (Manufacturer) :
Precision Medical Plastics Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable High-pressure Extension Lines is indicated for use as a connecting line for injection of contrast media or saline during coronary angiographic procedures.
Device Description
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