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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Non-Powered
510(k) Number K772013
Device Name PERCUPASS TUNNELING TOOL MODEL 3452
Applicant
Medtronic Vascular
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Medtronic Vascular
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number882.4535
Classification Product Code
HAO  
Date Received10/25/1977
Decision Date 10/28/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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