510(k) K022075

DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5 by Cp Medical — Product Code DSA

K022075 is an FDA 510(k) premarket notification submitted by Cp Medical for the device "DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5". The FDA issued a decision of Substantially Equivalent on September 19, 2002. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Cp Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2002
Date Received
June 26, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type