K192230 is an FDA 510(k) clearance for the MF SAFECATH. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Medifirst Co., Ltd. (Cheonan-Si, KR). The FDA issued a Cleared decision on April 23, 2020, 251 days after receiving the submission on August 16, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K192230 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2019 |
| Decision Date | April 23, 2020 |
| Days to Decision | 251 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOZ - Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |