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510(k) K891906

ROBICSEK INTRACARDIAC SUCTION WAND by Gish Biomedical, Inc. — Product Code DTS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1989
Date Received
March 27, 1989
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

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  • K080708 — VISION HOLLOW FIBER OXYGENATOR WITH HA COATING (February 2, 2009)
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  • K081881 — GISH TUBING AND CONNECTORS WITH HA COATING (January 23, 2009)

Other clearances for product code DTS

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  • 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)
  • K801641 — OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT (July 28, 1980)
  • K801400 — DISPOSABLE SUCKER SYSTEM (June 30, 1980)
  • K791846 — DISPOSSABLE SUCTION TUBE, 6 FRENCH (October 2, 1979)