The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Modification To Atlantis Sr Pro 2 And Sr Pro Coronary Imaging Catheters, Model 39014 And 38942.
| Device ID | K063312 |
| 510k Number | K063312 |
| Device Name: | MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BOSTON SCIENTIFIC CORP. 47900 BAYSIDE PARKWAY Fremont, CA 94538 -6515 |
| Contact | Robert Z Phillips |
| Correspondent | Robert Z Phillips BOSTON SCIENTIFIC CORP. 47900 BAYSIDE PARKWAY Fremont, CA 94538 -6515 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-02 |
| Decision Date | 2006-11-30 |
| Summary: | summary |