The following data is part of a premarket notification filed by Cardiothoracic Systems, Inc. with the FDA for Guidant Axius Coronary Shunt.
| Device ID | K010117 |
| 510k Number | K010117 |
| Device Name: | GUIDANT AXIUS CORONARY SHUNT |
| Classification | Clamp, Vascular |
| Applicant | CARDIOTHORACIC SYSTEMS, INC. 10600 NORTH TANTAU AVE. Cupertino, CA 95014 |
| Contact | Anne Schlagenhaft |
| Correspondent | Anne Schlagenhaft CARDIOTHORACIC SYSTEMS, INC. 10600 NORTH TANTAU AVE. Cupertino, CA 95014 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-16 |
| Decision Date | 2001-04-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607567700707 | K010117 | 000 |
| 00607567700608 | K010117 | 000 |
| 00607567700615 | K010117 | 000 |
| 00607567700622 | K010117 | 000 |
| 00607567700639 | K010117 | 000 |
| 00607567700646 | K010117 | 000 |
| 00607567700653 | K010117 | 000 |
| 00607567700660 | K010117 | 000 |
| 00607567700677 | K010117 | 000 |
| 00607567700684 | K010117 | 000 |
| 00607567700691 | K010117 | 000 |
| 00607567700592 | K010117 | 000 |