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 |