The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Emerge Ptca Dilatation Catheter.
| Device ID | K163174 |
| 510k Number | K163174 |
| Device Name: | Emerge PTCA Dilatation Catheter |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311 |
| Contact | Jane Horan |
| Correspondent | Jane Horan Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-14 |
| Decision Date | 2016-12-14 |
| Summary: | summary |