510(k) K923311

CONDUCER HEAT EXCHANGER by 3M Health Care, Sarns — Product Code DTR

K923311 is an FDA 510(k) premarket notification submitted by 3M Health Care, Sarns for the device "CONDUCER HEAT EXCHANGER". The FDA issued a decision of Substantially Equivalent on September 18, 1992. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. 3M Health Care, Sarns has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1992
Date Received
July 7, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heat-Exchanger, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4240
Review Panel
CV
Submission Type