The following data is part of a premarket notification filed by Medifirst Co., Ltd. with the FDA for Mf Safecath.
| Device ID | K192230 |
| 510k Number | K192230 |
| Device Name: | MF SAFECATH |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | MediFirst Co., Ltd. #1049-16, Charyeonggogae-ro, Gwangdeok-myeon, Dongnam-gu Cheonan-si, KR 31223 |
| Contact | Ha Tae Joo |
| Correspondent | Sanglok Lee Wise Company Inc. #303, 142, Gasan Digital 1-ro Geumcheon-gu, KR 08301 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-16 |
| Decision Date | 2020-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28800055100467 | K192230 | 000 |
| 28800055100306 | K192230 | 000 |
| 28800055100313 | K192230 | 000 |
| 28800055100320 | K192230 | 000 |
| 28800055100337 | K192230 | 000 |
| 28800055100344 | K192230 | 000 |
| 28800055100351 | K192230 | 000 |
| 28800055100368 | K192230 | 000 |
| 28800055100375 | K192230 | 000 |
| 28800055100382 | K192230 | 000 |
| 28800055100399 | K192230 | 000 |
| 28800055100405 | K192230 | 000 |
| 28800055100412 | K192230 | 000 |
| 28800055100429 | K192230 | 000 |
| 28800055100436 | K192230 | 000 |
| 28800055100443 | K192230 | 000 |
| 28800055100450 | K192230 | 000 |
| 28800055100290 | K192230 | 000 |