The following data is part of a premarket notification filed by Numed Inc. with the FDA for Bib Stent Placement Catheter.
| Device ID | K213915 |
| 510k Number | K213915 |
| Device Name: | BIB Stent Placement Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal, Dual-balloon |
| 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 | NVM |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-15 |
| Decision Date | 2022-01-12 |