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510(k) K131092

STEALTH 360 ORBITAL PAD SYSTEM by Cardio Systems, Inc. — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2013
Date Received
April 18, 2013
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

Other clearances by Cardio Systems, Inc.

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  • K934689 — LOW AIR LOSS MATTRESS, MODIFICATION (February 2, 1994)
  • K921500 — CENTRI-SAFE(TM) VALVE (September 15, 1992)
  • K882177 — ADD-ON TO CRITICAL PATIENT CARE BED (December 1, 1988)
  • K852736 — BAYLOR RAPID AUTOTRANSFUSION SYSTEM (September 18, 1985)
  • K792151 — OXYGENATOR GAS LINE FILTER (November 13, 1979)
  • K792152 — CARDIOPLEGIA SOLUTION ADMIN. SET (November 13, 1979)

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