The following data is part of a premarket notification filed by Boston Scientific with the FDA for Emerge Monorail Ptca Dilatation Catheter.
| Device ID | K220629 |
| 510k Number | K220629 |
| Device Name: | Emerge Monorail PTCA Dilatation Catheter |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | Boston Scientific Ballybrit Business Park, Ballybrit Galway, IE H91y868 |
| Contact | Aoife O'flaherty |
| Correspondent | Aoife O'flaherty Boston Scientific Ballybrit Business Park, Ballybrit Galway, IE H91y868 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-04 |
| Decision Date | 2022-03-24 |