510(k) K842133

EYRTHROCATH DOUBLE-LUMEN CENTRAL VENOUS by Cardio Search, Inc. — Product Code FOZ

K842133 is an FDA 510(k) premarket notification submitted by Cardio Search, Inc. for the device "EYRTHROCATH DOUBLE-LUMEN CENTRAL VENOUS". The FDA issued a decision of Substantially Equivalent on February 19, 1985. 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. Cardio Search, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1985
Date Received
May 30, 1984
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