The following data is part of a premarket notification filed by Estech, Inc. with the FDA for Remote Access Perfusion Cannula Left Axillary 21 French.
| Device ID | K032632 |
| 510k Number | K032632 |
| Device Name: | REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | ESTECH, INC. 4135 BLACKHAWK PLAZA CIRCLE SUITE 150 Danville, CA 94506 |
| Contact | Arthur Bertolero |
| Correspondent | Arthur Bertolero ESTECH, INC. 4135 BLACKHAWK PLAZA CIRCLE SUITE 150 Danville, CA 94506 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-26 |
| Decision Date | 2003-10-22 |
| Summary: | summary |