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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K043291
Device Name CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884
Applicant
Medtronic Vascular
1015 Gramsie Rd.
Shoreview,  MN  55126
Applicant Contact DAVID D COX
Correspondent
Medtronic Vascular
1015 Gramsie Rd.
Shoreview,  MN  55126
Correspondent Contact DAVID D COX
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/29/2004
Decision Date 12/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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