The following data is part of a premarket notification filed by Spectranetics, Inc. with the FDA for Bridge Occlusion Balloon.
| Device ID | K153530 |
| 510k Number | K153530 |
| Device Name: | Bridge Occlusion Balloon |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | SPECTRANETICS, INC. 9965 FEDERAL DRIVE Colorado Springs, CO 80921 |
| Contact | Christopher Mclellan |
| Correspondent | Christopher Mclellan SPECTRANETICS, INC. 9965 FEDERAL DRIVE Colorado Springs, CO 80921 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-09 |
| Decision Date | 2016-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813132024840 | K153530 | 000 |
| 00813132024666 | K153530 | 000 |
| 00813132023263 | K153530 | 000 |