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K Number
K000313

Validate with FDA (Live)

Device Name
TEARAWAY INTRODUCER SHEATH
Manufacturer
XENTEK MEDICAL, INC.
Date Cleared
2000-06-16

(136 days)

Product Code
DYB
Regulation Number
870.1340
Type
Traditional
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K043525,K112398,K120617,K122854,K123430,K153533
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).