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510(k) K890077

TRAUMAFUSE RAPID INFUSION DEVICE by The Traumafuse Co. — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1989
Date Received
January 9, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reservoir, Blood, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4400
Review Panel
CV
Submission Type

Other clearances by The Traumafuse Co.

  • K895162 — TRAUMAFUSE TRACH SHIELD (January 9, 1990)
  • K894721 — TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE (October 20, 1989)
  • K895132 — CONNELL-STEPHENS ENDO ANESS TUBE (October 13, 1989)

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