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510(k) K053021

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

K053021 is an FDA 510(k) premarket notification submitted by Estech, Inc. for the device "ESTECH CLEARVIEW MV ATRIAL DEPRESSOR". The FDA issued a decision of Substantially Equivalent on January 26, 2006. The device falls under product code DTS (Sucker, Cardiotomy Return, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4420. Estech, Inc. has at least 6 other 510(k) clearances on record.

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

Other clearances by Estech, Inc.

  • K133017 — ESTECH COBRA(R) GENESIS BIPOLAR CLAMP (October 7, 2013)
  • K052081 — REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA (December 16, 2005)
  • K051749 — COBRA SURGICAL SYSTEM (September 13, 2005)
  • K041599 — COBRA ADHERE SURGICAL SYSTEM (July 27, 2004)
  • K032632 — REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH (October 22, 2003)
  • K990573 — ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA (March 11, 1999)

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)

FDA data resources