The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Imager Ii Angiographic Catheter.
| Device ID | K121694 |
| 510k Number | K121694 |
| Device Name: | IMAGER II ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Holly Ramirez |
| Correspondent | Holly Ramirez BOSTON SCIENTIFIC CORP. 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 | 2012-06-07 |
| Decision Date | 2012-09-14 |
| Summary: | summary |