The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed Coefficient Ptv Catheters.
| Device ID | K014124 |
| 510k Number | K014124 |
| Device Name: | NUMED COEFFICIENT PTV CATHETERS |
| Classification | Pulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter |
| Applicant | NUMED, INC. 2880 MAIN ST. Hopkinton, NY 12965 |
| Contact | Nichelle R Laflash |
| Correspondent | Nichelle R Laflash NUMED, INC. 2880 MAIN ST. Hopkinton, NY 12965 |
| Product Code | OMZ |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-17 |
| Decision Date | 2002-01-16 |
| Summary: | summary |