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510(k) K060016

THROMCAT THROMBECTOMY CATHETER SYSTEM by Kensey Nash Corp. — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2006
Date Received
January 3, 2006
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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  • K073519 — QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 (March 28, 2008)
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  • K072195 — THROMCAT THROMBECTOMY CATHETER SYSTEM (August 23, 2007)
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  • K062870 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 (October 20, 2006)

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