The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Bib Stent Placement Catheter.
Device ID | K161451 |
510k Number | K161451 |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-05-26 |
Decision Date | 2016-09-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04046955049004 | K161451 | 000 |
04046955048991 | K161451 | 000 |
04046955048984 | K161451 | 000 |
04046955048977 | K161451 | 000 |
04046955048960 | K161451 | 000 |
04046955048953 | K161451 | 000 |
04046955048946 | K161451 | 000 |
04046955048939 | K161451 | 000 |
04046955048922 | K161451 | 000 |