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 |