meddevicedb.com FDA Device Reference

Surfacer Inside-Out Access Catheter System

DEN190038 Class II Direct
Decision Date
2020-02-10
Sponsor / Applicant
Bluegrass Vascular Technologies, Inc.

Technical Specification

510(k) Submission ID DEN190038
Product Code QJH
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.1342
Decision Date 2020-02-10
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

Surfacer Inside-Out Access Catheter System received FDA 510(k) clearance under submission number DEN190038, sponsored by Bluegrass Vascular Technologies, 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 2020-02-10.

Classification & Regulation

This clearance is catalogued under FDA product code QJH and 21 CFR 870.1342, within the Cardiovascular review panel as a Class II device.