meddevicedb.com FDA Device Reference

Permaseal

DEN150029 Class II Direct
Decision Date
2016-07-27
Sponsor / Applicant
Micro Interventional Devices,Inc.

Technical Specification

510(k) Submission ID DEN150029
Product Code PNQ
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.4510
Decision Date 2016-07-27
Clearance Pathway Direct

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

Permaseal received FDA 510(k) clearance under submission number DEN150029, sponsored by Micro Interventional Devices,Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2016-07-27.

Classification & Regulation

This clearance is catalogued under FDA product code PNQ and 21 CFR 870.4510, within the Cardiovascular review panel as a Class II device.