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510(k) K053021

ESTECH CLEARVIEW MV ATRIAL DEPRESSOR by Estech, Inc. — Product Code DTS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2006
Date Received
October 26, 2005
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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  • K032632 — REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH (October 22, 2003)
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Other clearances for product code DTS

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