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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 K131592
Device Name ENLIGHTN RENAL GUIDE CATHETER
Applicant
St. Jude Medical, Inc.
5050 Nathan Ln. N.
Plymouth,  MN  55442
Applicant Contact BLAIR SCHWARTZ
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/03/2013
Decision Date 01/31/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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