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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Catheter Tip
510(k) Number K161171
Device Name PressureWire X Guidewire
Applicant
St. Jude Medical, Inc.
5050 Nathan Ln. N.
Plymouth,  MN  55442
Applicant Contact HUDA YUSUF
Correspondent
St. Jude Medical, Inc.
5050 Nathan Ln. N.
Plymouth,  MN  55442
Correspondent Contact HUDA YUSUF
Regulation Number870.2870
Classification Product Code
DXO  
Subsequent Product Codes
DQX   DRG  
Date Received04/26/2016
Decision Date 08/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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