K821013 is an FDA 510(k) clearance for the IVEX-HP PEDIATRIC EXTENSION SET-SL. 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 July 30, 1982, 109 days after receiving the submission on April 12, 1982.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K821013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 1982 |
| Decision Date | July 30, 1982 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FPB — Filter, Infusion Line |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |