The following data is part of a premarket notification filed by Embol-x, Inc. with the FDA for Embol-x Aortic Occlusion And Cardioplegia Cannula.
| Device ID | K980631 |
| 510k Number | K980631 |
| Device Name: | EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA |
| Classification | Clamp, Vascular |
| Applicant | EMBOL-X, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
| Contact | Jean Chang |
| Correspondent | Jean Chang EMBOL-X, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-18 |
| Decision Date | 1999-02-02 |
| Summary: | summary |