The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed High Pressure Pta Catheters.
| Device ID | K010880 |
| 510k Number | K010880 |
| Device Name: | NUMED HIGH PRESSURE PTA CATHETERS |
| Classification | Catheter, Percutaneous |
| Applicant | NUMED, INC. 2880 MAIN ST. Hopkinton, NY 12965 |
| Contact | Nichelle R Laflesh |
| Correspondent | Nichelle R Laflesh NUMED, INC. 2880 MAIN ST. Hopkinton, NY 12965 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-23 |
| Decision Date | 2001-04-20 |