K041415 is an FDA 510(k) clearance for the EVA TPN CONTAINER. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).
Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on August 4, 2004, 69 days after receiving the submission on May 27, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K041415 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 2004 |
| Decision Date | August 04, 2004 |
| Days to Decision | 69 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 |