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 |