The following data is part of a premarket notification filed by Fiagon Gmbh with the FDA for Vensure Balloon Device, Vensure Nav Balloon Device.
| Device ID | K201472 |
| 510k Number | K201472 |
| Device Name: | VenSure Balloon Device, VenSure Nav Balloon Device |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | Fiagon GmbH Neuendorfstr. 23b Hennigsdorf, DE 16761 |
| Contact | Dirk Mucha |
| Correspondent | Dirk Mucha Fiagon GmbH Neuendorfstr. 23b Hennigsdorf, DE 16761 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-03 |
| Decision Date | 2020-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EFIAE0135162 | K201472 | 000 |
| EFIAE0135062 | K201472 | 000 |