K922214 is an FDA 510(k) clearance for the EMPTY VIAFLEX PLASTIC CONTAINER. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on March 26, 1993, 318 days after receiving the submission on May 12, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K922214 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 1992 |
| Decision Date | March 26, 1993 |
| Days to Decision | 318 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 |