K210749 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 August 19, 2021, 160 days after receiving the submission on March 12, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K210749 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2021 |
| Decision Date | August 19, 2021 |
| Days to Decision | 160 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 |