Estech Clearview MV Atrial Depressor
FDA 510(k) K053021 · Estech, Inc.
510(k) numberK053021
Submission
- Device name
- Estech Clearview MV Atrial Depressor
- Applicant
- Estech, Inc.
Alameda, CA, US - Received
- October 26, 2005
- Decision date
- January 26, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTS – Sucker, Cardiotomy Return, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4420
- Specialty
- Cardiovascular
Other 510(k)s with product code DTS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K982891 | California Medical Laboratories Inc. Standard and Small Rigid Tip Suction WandsDTS · Traditional | California Medical Laboratories, Inc. | 09/30/1998SE |
| K963756 | Ibc Cardiac Suction WardDTS · Traditional | International Biophysics Corp. | 11/14/1997SE |
| K905008 | Flexible Intracardiac Suction DeviceDTS · Traditional | Gish Biomedical, Inc. | 01/23/1991SE |
| K900339 | Hand-Held Intracardiac Suckers W/Ergonomic HandlesDTS · Traditional | Shiley, Inc. | 03/28/1990SE |
| K891906 | Robicsek Intracardiac Suction WandDTS · Traditional | Gish Biomedical, Inc. | 06/13/1989SE |
| K801641 | Ohio Disposable Clear Suction InstrumentDTS · Traditional | Ohio Medical Products | 07/28/1980SE |
| K801400 | Disposable Sucker SystemDTS · Traditional | Texas Medical Products, Inc. | 06/30/1980SE |
| K791846 | Dispossable Suction Tube, 6 FrenchDTS · Traditional | Dlp, Inc. | 10/02/1979SE |
More from Dlp, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K133017 | Estech Cobra(R) Genesis Bipolar ClampGEI · Special | 10/07/2013SE |
| K052081 | Remote Access Perfusion (Rap) Femoral Venous CannulaDWF · Traditional | 12/16/2005SE |
| K051749 | Cobra Surgical SystemGEI · Traditional | 09/13/2005SE |
| K041599 | Cobra Adhere Surgical SystemGEI · Traditional | 07/27/2004SE |
| K032632 | Remote Access Perfusion Cannula Left Axillary 21 FrenchDWF · Abbreviated | 10/22/2003SE |
| K990573 | Estech Arterial Remote Access Perfusion CannulaDXC · Traditional | 03/11/1999SE |
Questions and answers
When was Estech Clearview MV Atrial Depressor cleared by the FDA?
Estech Clearview MV Atrial Depressor (K053021) received a 510(k) decision of Substantially Equivalent on January 26, 2006, 92 days after the submission was received.
What is the product code of K053021?
The FDA product code is DTS – Sucker, Cardiotomy Return, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4420.