Submission Details
| 510(k) Number | K203540 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 03, 2020 |
| Decision Date | December 23, 2020 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Bridge Occlusion Balloon
Dec 2020
Decision
20d
Days
Class 2
Risk
About This 510(k) Submission
K203540 is an FDA 510(k) clearance for the Bridge Occlusion Balloon, 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 December 23, 2020, 20 days after receiving the submission on December 3, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.
Device Classification
| Product Code | MJN — Catheter, Intravascular Occluding, Temporary |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4450 |
Manufacturer
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