510(k) K860290

VIAPIC CENTRAL LINE CATHETER by Parke-Davis Co. — Product Code FOZ

K860290 is an FDA 510(k) premarket notification submitted by Parke-Davis Co. for the device "VIAPIC CENTRAL LINE CATHETER". The FDA issued a decision of Substantially Equivalent on March 18, 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. Parke-Davis Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1986
Date Received
January 28, 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