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510(k) K905008

FLEXIBLE INTRACARDIAC SUCTION DEVICE by Gish Biomedical, Inc. — Product Code DTS

K905008 is an FDA 510(k) premarket notification submitted by Gish Biomedical, Inc. for the device "FLEXIBLE INTRACARDIAC SUCTION DEVICE". The FDA issued a decision of Substantially Equivalent on January 23, 1991. The device falls under product code DTS (Sucker, Cardiotomy Return, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4420. Gish Biomedical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1991
Date Received
November 6, 1990
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 Gish Biomedical, Inc.

  • K090450 — MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT (September 18, 2009)
  • K090449 — MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT (September 18, 2009)
  • K091062 — MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 (August 4, 2009)
  • K083131 — MEDOS HILITE RESERVOIR, MODEL: 4030 (July 30, 2009)
  • K082403 — MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT (May 15, 2009)
  • K081947 — GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING (February 4, 2009)
  • K082082 — GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING (February 4, 2009)
  • K080708 — VISION HOLLOW FIBER OXYGENATOR WITH HA COATING (February 2, 2009)
  • K081838 — GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING (January 26, 2009)
  • K081881 — GISH TUBING AND CONNECTORS WITH HA COATING (January 23, 2009)

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)
  • 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)
  • K801400 — DISPOSABLE SUCKER SYSTEM (June 30, 1980)
  • K791846 — DISPOSSABLE SUCTION TUBE, 6 FRENCH (October 2, 1979)

FDA data resources