The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Boston Scientific Scimed Atlantis Coronary Imaging Catheter, Model C4020.
| Device ID | K000743 |
| 510k Number | K000743 |
| Device Name: | BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Deborah A Frank |
| Correspondent | Deborah A Frank BOSTON SCIENTIFIC SCIMED, INC. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-07 |
| Decision Date | 2000-09-06 |