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510(k) K982891

CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS by California Medical Laboratories, Inc. — Product Code DTS

K982891 is an FDA 510(k) premarket notification submitted by California Medical Laboratories, Inc. for the device "CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS". The FDA issued a decision of Substantially Equivalent on September 30, 1998. The device falls under product code DTS (Sucker, Cardiotomy Return, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4420. California Medical Laboratories, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1998
Date Received
August 17, 1998
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 California Medical Laboratories, Inc.

  • K000830 — CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE (September 7, 2000)
  • K993818 — ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE (February 8, 2000)

Other clearances for product code DTS

  • K053021 — ESTECH CLEARVIEW MV ATRIAL DEPRESSOR (January 26, 2006)
  • 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)
  • K801400 — DISPOSABLE SUCKER SYSTEM (June 30, 1980)
  • K791846 — DISPOSSABLE SUCTION TUBE, 6 FRENCH (October 2, 1979)

FDA data resources