The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Impulse And Expo Angiographic Catheter.
| Device ID | K120495 |
| 510k Number | K120495 |
| Device Name: | IMPULSE AND EXPO ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Yumi Wackerfuss |
| Correspondent | Yumi Wackerfuss BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-17 |
| Decision Date | 2012-05-21 |
| Summary: | summary |