The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Pts-x Sizing Balloon Catheter.
| Device ID | K131869 |
| 510k Number | K131869 |
| Device Name: | PTS-X SIZING BALLOON CATHETER |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | NUMED, INC. 2880 MAIN ST. Hopkinton, NY 12965 |
| Contact | Nichelle Laflesh |
| Correspondent | Nichelle Laflesh NUMED, INC. 2880 MAIN ST. Hopkinton, NY 12965 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-24 |
| Decision Date | 2013-08-08 |