The following data is part of a premarket notification filed by Marvao Medical Devices Ltd with the FDA for Boss Crossing Support Catheter.
| Device ID | K220632 |
| 510k Number | K220632 |
| Device Name: | Boss Crossing Support Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Marvao Medical Devices Ltd Unit 1 Galway Business Park, Dangan Galway, IE H91A3EF |
| Contact | Chris Davey |
| Correspondent | Mary P. LeGraw Avania Ltd 100 Crowley Drive, Suite 216 Marlborough, MA 01752 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-04 |
| Decision Date | 2022-06-02 |