The following data is part of a premarket notification filed by Boston Scientific/medi-tech with the FDA for Imager Ii Angiographic Catheter.
| Device ID | K011664 |
| 510k Number | K011664 |
| Device Name: | IMAGER II ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BOSTON SCIENTIFIC/MEDI-TECH ONE BOSTON SCIENTIFIC PLACE Natick, MA 01760 -1537 |
| Contact | Jodi L Greenizen |
| Correspondent | Jodi L Greenizen BOSTON SCIENTIFIC/MEDI-TECH ONE BOSTON SCIENTIFIC PLACE Natick, MA 01760 -1537 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-30 |
| Decision Date | 2001-09-07 |
| Summary: | summary |