meddevicedb.com FDA Device Reference

AMIGO REMOTE CATHETER SYSTEM

DEN140009 Class II Direct
Decision Date
2014-12-18
Sponsor / Applicant
Catheter Robotics, Inc.

Technical Specification

510(k) Submission ID DEN140009
Product Code PJB
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.5700
Decision Date 2014-12-18
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

AMIGO REMOTE CATHETER SYSTEM received FDA 510(k) clearance under submission number DEN140009, sponsored by Catheter Robotics, 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 2014-12-18.

Classification & Regulation

This clearance is catalogued under FDA product code PJB and 21 CFR 870.5700, within the Cardiovascular review panel as a Class II device.