K180801 is an FDA 510(k) clearance for the Actreen Hi-Lite Cath, Actreen Hi-Lite Set. This device is classified as a Catheter, Urethral (Class II - Special Controls, product code GBM).
Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on November 5, 2018, 222 days after receiving the submission on March 28, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K180801 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2018 |
| Decision Date | November 05, 2018 |
| Days to Decision | 222 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | GBM — Catheter, Urethral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |