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510(k) K193279

Comet II Pressure Guidewire by Boston Scientific Corporation — Product Code DXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2019
Date Received
November 27, 2019
Clearance Type
Special
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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