# K053021: Estech Clearview MV Atrial Depressor

- Pathway: 510(k) (Traditional)
- Applicant: Estech, Inc.
- Decided: Jan 26, 2006 after 92 days
- Product code: DTS (Sucker, Cardiotomy Return, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963756 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982891: California Medical Laboratories Inc. Standard and Small Rigid Tip Suction Wands, California Medical Laboratories, Inc. (1998) Summary page 1.
- K963756: Ibc Cardiac Suction Ward, International Biophysics Corp. (1997) Summary page 1.

## Indications for use
The ESTECH Clearview TM MV Atrial Depressor is intended to remove excess fluids from the surgical field for filtering and return to the patient during cardiopulmonary bypass of up to 6 hours. It can also be used to retract tissue to increase visibility.

Source page: https://510kreport.com/device/K053021
Methodology: https://510kreport.com/methodology