K200373 is an FDA 510(k) clearance for the Deltaven Fast Flash Closed I.V. Catheter Systems. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Delta Med Spa (Viadana, IT). The FDA issued a Cleared decision on August 26, 2020, 194 days after receiving the submission on February 14, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K200373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2020 |
| Decision Date | August 26, 2020 |
| Days to Decision | 194 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 |