The following data is part of a premarket notification filed by Hakki Medical Technologies, Inc. with the FDA for Lotuscatheter (lotus No Balloon Catheter).
| Device ID | K191512 |
| 510k Number | K191512 |
| Device Name: | LotusCatheter (Lotus No Balloon Catheter) |
| Classification | Catheter, Urethral |
| Applicant | Hakki Medical Technologies, Inc. 10333 Seminole Boulevard, Suite #8 Largo, FL 33778 |
| Contact | Shereen Said Hakky |
| Correspondent | John Samorajczyk Hakki Medical Technologies, Inc. 5414 Leilani Drive St. Petersburg Beach, FL 33778 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-07 |
| Decision Date | 2020-05-21 |