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510(k) K151610

Comet Pressure Guidewire by Boston Scientific Corporation — Product Code DXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2015
Date Received
June 15, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Pressure, Catheter Tip
Device Class
Class II
Regulation Number
870.2870
Review Panel
CV
Submission Type

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