K111217 is an FDA 510(k) clearance for the ADDITIVE CAP. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).
Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on June 14, 2011, 43 days after receiving the submission on May 2, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K111217 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2011 |
| Decision Date | June 14, 2011 |
| Days to Decision | 43 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 |