510(k) K861510

MULTILUMEN VIAPIC CENTRAL LINE CATHETER by Warner-Lambert Co. — Product Code FOZ

K861510 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "MULTILUMEN VIAPIC CENTRAL LINE CATHETER". The FDA issued a decision of Substantially Equivalent on June 9, 1986. 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. Warner-Lambert Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1986
Date Received
April 23, 1986
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