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510(k) K060904

CLEANER ROTATIONAL THROMBECTOMY SYSTEM by Rex Medical, L.P. — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2006
Date Received
April 3, 2006
Clearance Type
Special
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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