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510(k) K180558

PressureWire X by St. Jude Medical (Now Part of Abbott Medical) — Product Code DXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2018
Date Received
March 1, 2018
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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