K153530 is an FDA 510(k) clearance for the Bridge Occlusion Balloon. This device is classified as a Catheter, Intravascular Occluding, Temporary (Class II - Special Controls, product code MJN).
Submitted by Spectranetics, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on February 5, 2016, 58 days after receiving the submission on December 9, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K153530 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2015 |
| Decision Date | February 05, 2016 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MJN - Catheter, Intravascular Occluding, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |