Submission Details
| 510(k) Number | K140273 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 03, 2014 |
| Decision Date | July 22, 2014 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
EQUALIZER OCCLUSION BALLOON CATHETER
Jul 2014
Decision
169d
Days
Class 2
Risk
About This 510(k) Submission
K140273 is an FDA 510(k) clearance for the EQUALIZER OCCLUSION BALLOON CATHETER, a Catheter, Intravascular Occluding, Temporary (Class II — Special Controls, product code MJN), submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on July 22, 2014, 169 days after receiving the submission on February 3, 2014. 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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