The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed Pts X Sizing Balloon Catheter.
| Device ID | K041306 |
| 510k Number | K041306 |
| Device Name: | NUMED 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 | 2004-05-17 |
| Decision Date | 2004-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04046964512186 | K041306 | 000 |
| 04046964512056 | K041306 | 000 |
| 04046964512063 | K041306 | 000 |
| 04046964512087 | K041306 | 000 |
| 04046964512094 | K041306 | 000 |
| 04046964512100 | K041306 | 000 |
| 04046964512155 | K041306 | 000 |
| 04046964512179 | K041306 | 000 |
| 04046964512070 | K041306 | 000 |
| 04046964512162 | K041306 | 000 |
| 04046964512049 | K041306 | 000 |