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510(k) K092486

VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT by Vortex Medical, Inc. — Product Code DWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2009
Date Received
August 13, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Vortex Medical, Inc.

  • K133445 — ANGIOVAC CANNULA (March 5, 2014)
  • K091304 — VORTEX CANNULA (July 2, 2009)

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