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510(k) K841959

CARDIO METRIC CUSTOM PERFUSION TUBING by Sterile Design, Inc. — Product Code DWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1984
Date Received
May 14, 1984
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 Sterile Design, Inc.

  • K934688 — STERILE DESIGN (March 16, 1994)
  • K841960 — CARDIO METRICS INVASIVE PRESSURE MONIT (November 8, 1985)
  • K842356 — CUSTOM STERILE PROCEDURE KITS (March 21, 1985)
  • K842351 — STERILE DESIGN-CUSTOM STERILE IV KIT (October 15, 1984)
  • K841958 — CARDIO METRICS CARDIOTOMY RESERVOIR (October 15, 1984)
  • K834239 — SDI C-FLEX STERILE LIGHT HANDLE (April 25, 1984)
  • K834237 — GRADUATED GUIDE WIRE BOWL 8 (February 4, 1984)
  • K813437 — PAN SET (December 31, 1981)
  • K791738 — CUSTOM DRESSING CHANGE TRAYS (October 2, 1979)

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)