Cleared Traditional

K053021 - ESTECH CLEARVIEW MV ATRIAL DEPRESSOR

K053021 is an FDA 510(k) clearance for ESTECH CLEARVIEW MV ATRIAL DEPRESSOR, manufactured by Estech, Inc.. The device is a Class 2 Cardiovascular device with product code DTS cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K053021 · Estech, Inc. · Cardiovascular device
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Jan 2006
Decision
92d
Days
Class 2
Risk

K053021 is an FDA 510(k) clearance for the ESTECH CLEARVIEW MV ATRIAL DEPRESSOR. Classified as Sucker, Cardiotomy Return, Cardiopulmonary Bypass (product code DTS), Class II - Special Controls.

Submitted by Estech, Inc. (Alameda, US). The FDA issued a Cleared decision on January 26, 2006 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4420 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Estech, Inc. devices

FDA 510(k) Submission Details - K053021

510(k) Number K053021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2005
Decision Date January 26, 2006
Days to Decision 92 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTS Device Classification - Class 2, Special Controls

Product Code DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4420
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass

Devices cleared under the same product code (DTS) and FDA review panel - the closest regulatory comparables to K053021.
FLEXIBLE INTRACARDIAC SUCTION DEVICE
K905008 · Gish Biomedical, Inc. · Jan 1991
HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES
K900339 · Shiley, Inc. · Mar 1990
ROBICSEK INTRACARDIAC SUCTION WAND
K891906 · Gish Biomedical, Inc. · Jun 1989
OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT
K801641 · Ohio Medical Products · Jul 1980
DISPOSABLE SUCKER SYSTEM
K801400 · Texas Medical Products, Inc. · Jun 1980
DISPOSSABLE SUCTION TUBE, 6 FRENCH
K791846 · Dlp, Inc. · Oct 1979