K073538 is an FDA 510(k) clearance for the DUAL CHAMBER 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 March 12, 2008, 86 days after receiving the submission on December 17, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K073538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2007 |
| Decision Date | March 12, 2008 |
| Days to Decision | 86 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 |