510(k) K900116

DESERET OPTIMA INTRAVASCULAR CATHETER by Deseret Medical, Inc. — Product Code FOZ

K900116 is an FDA 510(k) premarket notification submitted by Deseret Medical, Inc. for the device "DESERET OPTIMA INTRAVASCULAR CATHETER". The FDA issued a decision of Substantially Equivalent on June 18, 1990. 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. Deseret Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1990
Date Received
January 9, 1990
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