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K Number
K121859
Device Name
TYSHAK NUCLEUS
Manufacturer
NUMED, INC.
Date Cleared
2012-08-31

(66 days)

Product Code
DQY,DOY
Regulation Number
870.1250
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

  • A patient with isolated pulmonary stenosis.
  • A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) clearance letter for the NuMED Inc. Tyshak NuCLEUS™ Catheter, which primarily addresses regulatory classification and substantial equivalence to predicate devices, along with indications for use. It does not include details on performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

§ 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).