510(k) K801414

ERYTHROCATH INTRAVENOUS CATHETER PLA. U. by G.D. Searle and Co. — Product Code FOZ

K801414 is an FDA 510(k) premarket notification submitted by G.D. Searle and Co. for the device "ERYTHROCATH INTRAVENOUS CATHETER PLA. U.". The FDA issued a decision of Substantially Equivalent on August 13, 1980. 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. G.D. Searle and Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1980
Date Received
June 16, 1980
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