SARNS 8000 MODULAR PERFUSION SYSTEM

Console, Heart-lung Machine, Cardiopulmonary Bypass

The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns 8000 Modular Perfusion System.

Device ID	K915183
510k Number	K915183
Device Name:	SARNS 8000 MODULAR PERFUSION SYSTEM
Classification	Console, Heart-lung Machine, Cardiopulmonary Bypass
Applicant	3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106
Contact	James Balun
Correspondent	James Balun 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106
Product Code	DTQ
Subsequent Product Code	DTW
Subsequent Product Code	DWA
Subsequent Product Code	DWB
Subsequent Product Code	DWC
Subsequent Product Code	KRI
Subsequent Product Code	KRL
CFR Regulation Number	870.4220 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	1991-11-18
Decision Date	1992-07-08