meddevicedb.com FDA Device Reference

Ellipsys Vascular Access System

DEN170004 Class II Direct
Decision Date
2018-06-22
Sponsor / Applicant
Avenu Medical, Inc.

Technical Specification

510(k) Submission ID DEN170004
Product Code PQK
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.1252
Decision Date 2018-06-22
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

Ellipsys Vascular Access System received FDA 510(k) clearance under submission number DEN170004, sponsored by Avenu Medical, 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 2018-06-22.

Classification & Regulation

This clearance is catalogued under FDA product code PQK and 21 CFR 870.1252, within the Cardiovascular review panel as a Class II device.