510(k) K222185

Device

Stratus Infusion Catheter

Applicant

Intervene, Inc.

510(k) number

K222185

Product code

NPG

Decision

Substantially Equivalent (SESE)

Decision date

2023-04-13

Date received

2022-07-22

Regulation

870.1210

Classification name

Catheter, Infusion, Syringe

Medical specialty

Cardiovascular

Review panel

Cardiovascular

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N