510(k) K173923

Temporary Cardiac Pacing Wire by ETHICON, Inc. — Product Code LDF

K173923 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "Temporary Cardiac Pacing Wire". The FDA issued a decision of Substantially Equivalent on August 2, 2018. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. ETHICON, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2018
Date Received
December 26, 2017
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