The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Impulse Angiographic Catheter, Expo Angiographic Catheter.
| Device ID | K152605 |
| 510k Number | K152605 |
| Device Name: | Impulse Angiographic Catheter, Expo Angiographic Catheter |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BOSTON SCIENTIFIC CORPORATION One Scimed Place Maple Grove, MN 55311 |
| Contact | Mac Mckeen |
| Correspondent | Mac Mckeen BOSTON SCIENTIFIC CORPORATION One Scimed Place Maple Grove, MN 55311 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-11 |
| Decision Date | 2015-10-29 |
| Summary: | summary |