The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Boston Scientific Imager Ii 4f Selective Angiographic Catheter.
| Device ID | K022621 |
| 510k Number | K022621 |
| Device Name: | BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Contact | Heidi M Erickson |
| Correspondent | Heidi M Erickson BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-07 |
| Decision Date | 2002-09-04 |
| Summary: | summary |