The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Pta-os Sizing Balloon, Model 360.
| Device ID | K003320 |
| 510k Number | K003320 |
| Device Name: | PTA-OS SIZING BALLOON, MODEL 360 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-24 |
| Decision Date | 2001-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04046964311055 | K003320 | 000 |
| 04046964311031 | K003320 | 000 |
| 04046964311017 | K003320 | 000 |
| 04046964310997 | K003320 | 000 |
| 04046964310973 | K003320 | 000 |
| 04046964310959 | K003320 | 000 |
| 04046964310935 | K003320 | 000 |
| 04046964310911 | K003320 | 000 |