The following data is part of a premarket notification filed by Spectranetics, Inc. with the FDA for Bridge Occlusion Balloon.
| Device ID | K203540 |
| 510k Number | K203540 |
| Device Name: | Bridge Occlusion Balloon |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | Spectranetics, Inc. 9965 Federal Drive Colorado Springs, CO 80921 |
| Contact | Sondra Chandler |
| Correspondent | Sondra Chandler Spectranetics, Inc. 9965 Federal Drive Colorado Springs, CO 80921 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-03 |
| Decision Date | 2020-12-23 |