K193528 is an FDA 510(k) clearance for the Empty EVA Bag. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).
Submitted by Haemotronic S.P.A. (Mirandola, IT). The FDA issued a Cleared decision on July 22, 2020, 216 days after receiving the submission on December 19, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K193528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2019 |
| Decision Date | July 22, 2020 |
| Days to Decision | 216 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KPE - Container, I.v. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5025 |