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510(k) K072195

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2007
Date Received
August 7, 2007
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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  • K062870 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 (October 20, 2006)
  • K061772 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM (July 11, 2006)

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