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510(k) K191419

Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire by Rex Medical, L.P. — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2019
Date Received
May 28, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peripheral, Atherectomy
Device Class
Class II
Regulation Number
870.4875
Review Panel
CV
Submission Type

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