510(k) K861479

CAVAFIX, CENTRAL VENOUS CATHETER KIT by Burron Medical Products, Inc. — Product Code FOZ

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
July 1, 1986
Date Received
April 22, 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