The following data is part of a premarket notification filed by Estech, Inc. with the FDA for Estech Arterial Remote Access Perfusion Cannula.
| Device ID | K990573 |
| 510k Number | K990573 |
| Device Name: | ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA |
| Classification | Clamp, Vascular |
| Applicant | ESTECH, INC. 4115 BLACKHAWK PLAZA CIRCLE #100 Danville, CA 94506 |
| Contact | Arthur Bertolero |
| Correspondent | Arthur Bertolero ESTECH, INC. 4115 BLACKHAWK PLAZA CIRCLE #100 Danville, CA 94506 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-23 |
| Decision Date | 1999-03-11 |
| Summary: | summary |