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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K062727
Device Name CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE
Applicant
Medtronic Vascular
7601 Northland Dr.
Brooklyn Park,  MN  55428
Applicant Contact SCOTT CANDY
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/13/2006
Decision Date 10/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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