510(k) K171931

Celerity ECG Cable Accessory Pack by Medcomp (Medical Components, Inc.) — Product Code LJS

K171931 is an FDA 510(k) premarket notification submitted by Medcomp (Medical Components, Inc.) for the device "Celerity ECG Cable Accessory Pack". The FDA issued a decision of Substantially Equivalent on October 26, 2017. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Medcomp (Medical Components, Inc.) has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2017
Date Received
June 28, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type