510(k) K833112

TUBING FOR CARDIOPULMONARY BYPASS by Cardio Med Supplies, Inc. — Product Code DWF

K833112 is an FDA 510(k) premarket notification submitted by Cardio Med Supplies, Inc. for the device "TUBING FOR CARDIOPULMONARY BYPASS". The FDA issued a decision of Substantially Equivalent on November 28, 1983. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Cardio Med Supplies, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1983
Date Received
August 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type