meddevicedb.com FDA Device Reference

INFLOW INTRAURETHRAL VALVE-PUMP

DEN130044 Class II Direct
Decision Date
2014-10-14
Sponsor / Applicant
Vesiflo, Inc.

Technical Specification

510(k) Submission ID DEN130044
Product Code PIH
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.5140
Decision Date 2014-10-14
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

INFLOW INTRAURETHRAL VALVE-PUMP received FDA 510(k) clearance under submission number DEN130044, sponsored by Vesiflo, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2014-10-14.

Classification & Regulation

This clearance is catalogued under FDA product code PIH and 21 CFR 876.5140, within the Gastroenterology, Urology review panel as a Class II device.