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K Number
K003114

Validate with FDA (Live)

Device Name
NUMED TYSHAK AND Z-MED PTV CATHETERS
Manufacturer
NUMED, INC.
Date Cleared
2000-11-01

(27 days)

Product Code
LIT
Regulation Number
870.1250
Type
Special
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K040830
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).