Submission Details
| 510(k) Number | K210749 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Empty EVA Bag
Aug 2021
Decision
160d
Days
Class 2
Risk
About This 510(k) Submission
K210749 is an FDA 510(k) clearance for the Empty EVA Bag, 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 review panel. Regulated under 21 CFR 880.5025.
Device Classification
| Product Code | KPE — Container, I.v. |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5025 |
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