Submission Details
| 510(k) Number | K132990 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 24, 2013 |
| Decision Date | October 22, 2013 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
OCCLUSION BALLOON CATHETER
Oct 2013
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K132990 is an FDA 510(k) clearance for the 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 October 22, 2013, 28 days after receiving the submission on September 24, 2013. 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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