K964853 is an FDA 510(k) clearance for the INTRAVIA CONTAINER, EMPTY. 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 31, 1997, 118 days after receiving the submission on December 3, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K964853 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 1996 |
| Decision Date | March 31, 1997 |
| Days to Decision | 118 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 |