The following data is part of a premarket notification filed by Estech, Inc. with the FDA for Estech Clearview Mv Atrial Depressor.
| Device ID | K053021 |
| 510k Number | K053021 |
| Device Name: | ESTECH CLEARVIEW MV ATRIAL DEPRESSOR |
| Classification | Sucker, Cardiotomy Return, Cardiopulmonary Bypass |
| Applicant | ESTECH, INC. 1193 SHERMAN STREET Alameda, CA 94501 |
| Contact | Craig Coombs |
| Correspondent | Craig Coombs ESTECH, INC. 1193 SHERMAN STREET Alameda, CA 94501 |
| Product Code | DTS |
| CFR Regulation Number | 870.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-26 |
| Decision Date | 2006-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818354013962 | K053021 | 000 |
| 00818354013955 | K053021 | 000 |