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510(k) K801394

CARDIOPULMONARY BYPASS PUMP TUBING by Texas Medical Products, Inc. — Product Code DWE

K801394 is an FDA 510(k) premarket notification submitted by Texas Medical Products, Inc. for the device "CARDIOPULMONARY BYPASS PUMP TUBING". The FDA issued a decision of Substantially Equivalent on June 30, 1980. The device falls under product code DWE (Tubing, Pump, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4390. Texas Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1980
Date Received
June 13, 1980
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 Texas Medical Products, Inc.

  • K893417 — SURGIFRESH SUB-MICRON MASK NO. 901008-000 (June 22, 1989)
  • K870932 — SURGIFRESH SURGICAL SMOKE REMOVAL (March 31, 1987)
  • K851575 — DR. BRUNO LNAGE MINI PHOTOMETER (October 18, 1985)
  • K830634 — CARDIOTOMY FILTER (June 30, 1983)
  • K813587 — DISPOSABLE THORACIC CATHETER (January 12, 1982)
  • K810532 — DISPOSABLE STOPCOCK (April 23, 1981)
  • K810515 — DISPOSABLE 2-STAGE CANNULA (April 23, 1981)
  • K810395 — PRE-BYPASS FILTER (March 5, 1981)
  • K802544 — DISPOSABLE QUICK RELEASE PERFUSION ADAP (January 16, 1981)
  • K802539 — DISPOSABLE GAS LINE FILTER (January 16, 1981)

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