510(k) K191512 ยท GBM Catheter, Urethral
LotusCatheter (Lotus No Balloon Catheter)
| Applicant | Hakki Medical Technologies, Inc., Largo FL, US |
| Decision | Unknown, May 21, 2020 |
| Received | Jun 7, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191512
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.