The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed Mullins X Pta Catheter.
| Device ID | K041093 |
| 510k Number | K041093 |
| Device Name: | NUMED MULLINS X PTA CATHETER |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-27 |
| Decision Date | 2004-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04046964316586 | K041093 | 000 |
| 04046964316562 | K041093 | 000 |
| 04046964316548 | K041093 | 000 |
| 04046964316524 | K041093 | 000 |