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510(k) K801400

DISPOSABLE SUCKER SYSTEM by Texas Medical Products, Inc. — Product Code DTS

K801400 is an FDA 510(k) premarket notification submitted by Texas Medical Products, Inc. for the device "DISPOSABLE SUCKER SYSTEM". The FDA issued a decision of Substantially Equivalent on June 30, 1980. The device falls under product code DTS (Sucker, Cardiotomy Return, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4420. 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
Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4420
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)
  • K802541 — DISPOSABLE PARALLEL Y CONNECTORS (January 16, 1981)

Other clearances for product code DTS

  • K053021 — ESTECH CLEARVIEW MV ATRIAL DEPRESSOR (January 26, 2006)
  • K982891 — CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS (September 30, 1998)
  • K963756 — IBC CARDIAC SUCTION WARD (November 14, 1997)
  • K905008 — FLEXIBLE INTRACARDIAC SUCTION DEVICE (January 23, 1991)
  • K900339 — HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES (March 28, 1990)
  • K891906 — ROBICSEK INTRACARDIAC SUCTION WAND (June 13, 1989)
  • K801641 — OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT (July 28, 1980)
  • K791846 — DISPOSSABLE SUCTION TUBE, 6 FRENCH (October 2, 1979)

FDA data resources