510(k) K251186

Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) by C.R. Bard, Inc. — Product Code LDF

K251186 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)". The FDA issued a decision of Substantially Equivalent on May 15, 2025. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2025
Date Received
April 16, 2025
Clearance Type
Special
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