K932477 is an FDA 510(k) clearance for the UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET. 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 June 10, 1994, 382 days after receiving the submission on May 24, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K932477 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 1993 |
| Decision Date | June 10, 1994 |
| Days to Decision | 382 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 |