K982822 is an FDA 510(k) clearance for the FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72. This device is classified as a Microfilter, Blood Transfusion (Class II - Special Controls, product code CAK).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on September 30, 1998, 50 days after receiving the submission on August 11, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K982822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 1998 |
| Decision Date | September 30, 1998 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | CAK — Microfilter, Blood Transfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |