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510(k) K212351

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2021
Date Received
July 29, 2021
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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  • K141617 — CLEANER ROTATIONAL THROMBECTOMY SYSTEM (November 14, 2014)
  • K133243 — OPTION ELITE VENA CAVA FILTER SYSTEM (December 17, 2013)
  • K060904 — CLEANER ROTATIONAL THROMBECTOMY SYSTEM (April 28, 2006)
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