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510(k) K920936

RMI EXTERNAL CORONARY ARTERY OCCLUDER by Research Medical, Inc. — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1992
Date Received
February 28, 1992
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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  • K960098 — RMI INTERNAL MAMMARY ARTERY CANNULA (March 26, 1996)
  • K951344 — RMI HEMOCONCENTRATOR (August 15, 1995)
  • K922083 — RMI SURGICCAL SITE VISUALIZATION WAND (January 29, 1993)
  • K915869 — RMI NORMOCLUDER CORONARY ARTERY OCCLUDER (December 8, 1992)
  • K920676 — RMI SOFCLAMP (April 15, 1992)
  • K910221 — RMI VASCULAR TOURNIQUET KIT (May 16, 1991)
  • K901231 — RMI CARDIOPLEGIA DELIVERY KITS (June 8, 1990)

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