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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
510(k) Number K013517
Device Name 10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVE. N.E.
MINNEAPOLIS,  MN  55432
Applicant Contact KRISTY K MOLLNER
Correspondent
MEDTRONIC VASCULAR
7000 CENTRAL AVE. N.E.
MINNEAPOLIS,  MN  55432
Correspondent Contact KRISTY K MOLLNER
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/22/2001
Decision Date 04/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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