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510(k) K970611

ORIGIN CARDIAC STABLIZER OCCLUDER by Origin Medsystems, Inc. — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1997
Date Received
February 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type

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  • K965121 — CANNULA (March 20, 1997)
  • K964171 — VASOVIEW BALLOON DISSECTION SYSTEM (February 14, 1997)
  • K962104 — AIRLIFT BALLOON RETRACTON SYSTEM (September 11, 1996)
  • K962005 — EXTRAHAND BALLOON RETRACTOR (August 12, 1996)
  • K960936 — RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES] (July 24, 1996)
  • K960637 — 5MM ENDOSCOPE (June 14, 1996)
  • K955163 — DISSECTION PROBE (January 24, 1996)

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