The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Pta, Ptv, Atrioseptostomy, Angiographic, Sizing Catheters.
| Device ID | K040830 |
| 510k Number | K040830 |
| Device Name: | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS |
| Classification | Catheter, Intravascular, Diagnostic |
| 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 | DQO |
| Subsequent Product Code | DQY |
| Subsequent Product Code | DXF |
| Subsequent Product Code | LIT |
| Subsequent Product Code | MJN |
| Subsequent Product Code | OMZ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-31 |
| Decision Date | 2004-06-18 |
| Summary: | summary |