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510(k) K910221

RMI VASCULAR TOURNIQUET KIT by Research Medical, Inc. — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1991
Date Received
January 17, 1991
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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  • K922083 — RMI SURGICCAL SITE VISUALIZATION WAND (January 29, 1993)
  • K920936 — RMI EXTERNAL CORONARY ARTERY OCCLUDER (December 18, 1992)
  • K915869 — RMI NORMOCLUDER CORONARY ARTERY OCCLUDER (December 8, 1992)
  • K920676 — RMI SOFCLAMP (April 15, 1992)
  • K901231 — RMI CARDIOPLEGIA DELIVERY KITS (June 8, 1990)

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