510(k) K973639

ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC. by J-Lloyd Medical, Inc. — Product Code DRF

K973639 is an FDA 510(k) premarket notification submitted by J-Lloyd Medical, Inc. for the device "ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.". The FDA issued a decision of Substantially Equivalent on April 20, 1998. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. J-Lloyd Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1998
Date Received
September 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type