K913308 is an FDA 510(k) clearance for the IVEX-TPN EXTENSION FILTER SET. This device is classified as a Filter, Infusion Line (Class II - Special Controls, product code FPB).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 15, 1992, 174 days after receiving the submission on July 25, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K913308 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 1991 |
| Decision Date | January 15, 1992 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FPB — Filter, Infusion Line |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |