The following data is part of a premarket notification filed by Boston Scientific, Target with the FDA for Atlantis Sr Plus Coronary Imaging Catheter, Model 35975.
| Device ID | K010707 |
| 510k Number | K010707 |
| Device Name: | ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975 |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
| Contact | Irene Jaworski |
| Correspondent | Irene Jaworski BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-09 |
| Decision Date | 2001-03-29 |