Search Results
Found 1 results
510(k) Data Aggregation
K Number
K131144Device Name
AMECO SHEATH INTRODUCERManufacturer
Date Cleared
2013-08-15
(114 days)
Product Code
Regulation Number
870.1340Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Percutaneous sheath introducer is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth for a medical device. The document is an FDA 510(k) clearance letter for an "Ameco Sheath Introducer" and primarily addresses its regulatory status and substantial equivalence to predicate devices. It outlines general controls, regulations, and contact information, but it does not include any performance study data or detailed information that would allow me to answer your questions.
Ask a Question
Ask a specific question about this device
Page 1 of 1