The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Z-6 Atrioseptostomy Catheter.
Device ID | K211910 |
510k Number | K211910 |
Device Name: | Z-6 Atrioseptostomy Catheter |
Classification | Catheter, Septostomy |
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 | DXF |
CFR Regulation Number | 870.5175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-06-21 |
Decision Date | 2021-07-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04046955718054 | K211910 | 000 |
04046955718047 | K211910 | 000 |