510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053021Substantially Equivalent

Estech Clearview Mv Atrial Depressor

Estech, Inc., Alameda CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053021 is the FDA 510(k) clearance record for ESTECH CLEARVIEW MV ATRIAL DEPRESSOR, a class II device, cleared for Estech, Inc. on under FDA product code DTS (Sucker, Cardiotomy Return, Cardiopulmonary Bypass). FDA records list 7 510(k) clearances for Estech, Inc., from to . As of , FDA records show no recalls naming K053021.

Clearance record

Decision date
Received
(92 days to decision)
Product code
DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Regulation
21 CFR 870.4420
Device class
Class II
Review panel
Cardiovascular
Applicant
Estech, Inc. 1193 Sherman St., Alameda CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DTS

Trailing 12 months

FDA records hold no clearances under product code DTS in the trailing twelve months.

FDA records show no clearances under product code DTS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260