510(k) K232926

Device

Novalung ultimate kit (US)

Applicant

Fresenius Medical Care Renal Therapies Group, LLC

510(k) number

K232926

Product code

QJZ

Decision

Substantially Equivalent (SESE)

Decision date

2024-04-15

Date received

2023-09-20

Regulation

870.4100

Classification name

Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure

Medical specialty

Cardiovascular

Review panel

Cardiovascular

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No