meddevicedb.com FDA Device Reference

NUCLEUS-X PTV CATHETER

DEN080015 Class II Post-NSE
Decision Date
2012-06-11
Sponsor / Applicant
NuMED, Inc.

Technical Specification

510(k) Submission ID DEN080015
Product Code OZT
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.1255
Decision Date 2012-06-11
Clearance Pathway Post-NSE

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

NUCLEUS-X PTV CATHETER received FDA 510(k) clearance under submission number DEN080015, sponsored by NuMED, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-06-11.

Classification & Regulation

This clearance is catalogued under FDA product code OZT and 21 CFR 870.1255, within the Cardiovascular review panel as a Class II device.