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510(k) K993062

CHEST DRAINAGE TUBING by Olson Medical Sales, Inc. — Product Code DWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1999
Date Received
September 13, 1999
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 Olson Medical Sales, Inc.

  • K000977 — COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS (March 23, 2001)
  • K993060 — GAS FILTER (March 28, 2000)
  • K992906 — COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT (November 10, 1999)

Other clearances for product code DWE

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  • 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)
  • K981613 — COBE SMARXT TUBING AND CONNECTORS (October 26, 1998)