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510(k) K923231

CARDIO-PAK BASIC PUMP PACK by Cardio-Med-Associates, Inc. — Product Code DWE

K923231 is an FDA 510(k) premarket notification submitted by Cardio-Med-Associates, Inc. for the device "CARDIO-PAK BASIC PUMP PACK". The FDA issued a decision of Substantially Equivalent (kit) on July 9, 1993. The device falls under product code DWE (Tubing, Pump, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4390. Cardio-Med-Associates, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
July 9, 1993
Date Received
July 1, 1992
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 Cardio-Med-Associates, Inc.

  • K923233 — CARDIO-PAK LAPAROTOMY PACK (March 20, 1993)

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)

FDA data resources