K840248 is an FDA 510(k) clearance for the IV-FILTER. This device is classified as a Filter, Infusion Line (Class II - Special Controls, product code FPB).
Submitted by Tri-Med, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 20, 1984, 92 days after receiving the submission on January 19, 1984.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K840248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 1984 |
| Decision Date | April 20, 1984 |
| Days to Decision | 92 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 |