510(k) K890988

MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE by Pace Medical — Product Code LDF

K890988 is an FDA 510(k) premarket notification submitted by Pace Medical for the device "MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE". The FDA issued a decision of Substantially Equivalent on August 25, 1989. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Pace Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1989
Date Received
February 27, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Pacemaker, Temporary
Device Class
Class II
Regulation Number
870.3680
Review Panel
CV
Submission Type