The following data is part of a premarket notification filed by Numed, Inc with the FDA for Bib Stent Placement Catheter.
| Device ID | K211134 |
| 510k Number | K211134 |
| Device Name: | BIB Stent Placement Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal, Dual-balloon |
| Applicant | NuMED, Inc 2880 Main Street Hopkinton, NY 12965 |
| Contact | Nichelle Laflesh |
| Correspondent | Nichelle Laflesh NuMED, Inc 2880 Main Street 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 | 2021-04-16 |
| Decision Date | 2021-05-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04046955719259 | K211134 | 000 |
| 04046955718597 | K211134 | 000 |
| 04046955718603 | K211134 | 000 |
| 04046955718610 | K211134 | 000 |
| 04046955718627 | K211134 | 000 |
| 04046955718634 | K211134 | 000 |
| 04046955718641 | K211134 | 000 |
| 04046955718658 | K211134 | 000 |
| 04046955718665 | K211134 | 000 |
| 04046955718672 | K211134 | 000 |
| 04046955718689 | K211134 | 000 |
| 04046955718696 | K211134 | 000 |
| 04046955718702 | K211134 | 000 |
| 04046955718719 | K211134 | 000 |
| 04046955718726 | K211134 | 000 |
| 04046955718733 | K211134 | 000 |
| 04046955718740 | K211134 | 000 |
| 04046955718580 | K211134 | 000 |