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510(k) K894721

TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE by The Traumafuse Co. — Product Code DWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1989
Date Received
July 25, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Pump, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4390
Review Panel
CV
Submission Type

Other clearances by The Traumafuse Co.

  • K895162 — TRAUMAFUSE TRACH SHIELD (January 9, 1990)
  • K895132 — CONNELL-STEPHENS ENDO ANESS TUBE (October 13, 1989)
  • K890077 — TRAUMAFUSE RAPID INFUSION DEVICE (April 3, 1989)

Other clearances for product code DWE

  • K233702 — SMARxT Tubing and Connectors (August 8, 2024)
  • K150542 — Terumo Pump Tubing (May 1, 2015)
  • K142607 — AngioVac Circuit (December 11, 2014)
  • K092486 — VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT (August 28, 2009)
  • K080592 — HLM TUBING SET WITH BIOLINE COATING (September 11, 2008)
  • K053025 — JOSTRA HLM TUBING SET (November 10, 2005)
  • K022857 — PUMP TUBING WITH X-COATING (September 19, 2002)
  • K013578 — PUMP TUBING (January 22, 2002)
  • K993189 — CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUM (March 1, 2000)
  • K993062 — CHEST DRAINAGE TUBING (December 10, 1999)