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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous, Intraspinal, Short Term
510(k) Number K934939
Device Name TEMPORARY SCREENING LEAD/ CATHETER KIT
Applicant
Medtronic Vascular
800 53rd Ave. NE
Minneapolis,  MN  55421
Applicant Contact DAVID H MUELLER
Correspondent
Medtronic Vascular
800 53rd Ave. NE
Minneapolis,  MN  55421
Correspondent Contact DAVID H MUELLER
Regulation Number868.5120
Classification Product Code
MAJ  
Date Received10/18/1993
Decision Date 05/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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