The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Bib Pta Balloon Catheter.
| Device ID | K050857 |
| 510k Number | K050857 |
| Device Name: | BIB PTA BALLOON CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal, Dual-balloon |
| Applicant | NUMED, INC. 2880 MAIN ST. Hopkinton, NY 12965 |
| Contact | Jodi Gijanto |
| Correspondent | Jodi Gijanto NUMED, INC. 2880 MAIN ST. Hopkinton, NY 12965 |
| Product Code | NVM |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-05 |
| Decision Date | 2005-07-28 |
| Summary: | summary |