510(k) K955839

MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER by Baxter Edwards — Product Code FOZ

K955839 is an FDA 510(k) premarket notification submitted by Baxter Edwards for the device "MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER". The FDA issued a decision of Substantially Equivalent on March 25, 1996. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Baxter Edwards has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1996
Date Received
December 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type