K960466 is an FDA 510(k) clearance for the IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION). This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 29, 1996, 148 days after receiving the submission on January 2, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K960466 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 1996 |
| Decision Date | May 29, 1996 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LHI — Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |