K201472 is an FDA 510(k) clearance for the VenSure Balloon Device, VenSure Nav Balloon Device. This device is classified as a Instrument, Ent Manual Surgical (Class I - General Controls, product code LRC).
Submitted by Fiagon GmbH (Hennigsdorf, DE). The FDA issued a Cleared decision on August 26, 2020, 84 days after receiving the submission on June 3, 2020.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K201472 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2020 |
| Decision Date | August 26, 2020 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | LRC - Instrument, Ent Manual Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4420 |