K131869 is an FDA 510(k) clearance for the PTS-X SIZING BALLOON CATHETER. This device is classified as a Catheter, Intravascular Occluding, Temporary (Class II - Special Controls, product code MJN).
Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on August 8, 2013, 45 days after receiving the submission on June 24, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K131869 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2013 |
| Decision Date | August 08, 2013 |
| Days to Decision | 45 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | MJN — Catheter, Intravascular Occluding, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |