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510(k) K830634

CARDIOTOMY FILTER by Texas Medical Products, Inc. — Product Code JOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1983
Date Received
March 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4270
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)
  • 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)
  • K802541 — DISPOSABLE PARALLEL Y CONNECTORS (January 16, 1981)
  • K802543 — RIDGID VENA CAVA CANNULAE (January 16, 1981)
  • K802545 — CARDIOPLEGIC SETS (January 16, 1981)

Other clearances for product code JOD

  • K993060 — GAS FILTER (March 28, 2000)
  • K890504 — CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS (March 10, 1989)
  • K875095 — PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE (February 29, 1988)
  • K874405 — PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE (December 30, 1987)
  • K855067 — SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 (February 26, 1986)
  • K841958 — CARDIO METRICS CARDIOTOMY RESERVOIR (October 15, 1984)
  • K823259 — INTERFACE CARDIOTOMY BLOOD FILTER #50 (November 24, 1982)
  • K823260 — INTERFACE CARDIOTOMY BLOOD FILTER #51 (November 24, 1982)
  • K812243 — INTERFACE CARDIOTOMY BLOOD FILTER #51 (August 25, 1981)
  • K781383 — INTERFACE CARDIOTOMY BLOOD FILTER (September 27, 1978)