510(k) K852060

INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123 by Cardiac Pacemakers, Inc. — Product Code FRN

K852060 is an FDA 510(k) premarket notification submitted by Cardiac Pacemakers, Inc. for the device "INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123". The FDA issued a decision of Substantially Equivalent on June 7, 1985. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Cardiac Pacemakers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1985
Date Received
May 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type