K172567 is an FDA 510(k) clearance for the GORE Molding and Occlusion Balloon Catheter. This device is classified as a Catheter, Intravascular Occluding, Temporary (Class II - Special Controls, product code MJN).
Submitted by W. L. Gore and Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on January 31, 2018, 159 days after receiving the submission on August 25, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K172567 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2017 |
| Decision Date | January 31, 2018 |
| Days to Decision | 159 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 |