K113227 is an FDA 510(k) clearance for the NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER. This device is classified as a Filter, Infusion Line (Class II - Special Controls, product code FPB).
Submitted by Baxter Healthcare Corp (Deerfield, US). The FDA issued a Cleared decision on December 8, 2011, 37 days after receiving the submission on November 1, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K113227 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2011 |
| Decision Date | December 08, 2011 |
| Days to Decision | 37 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPB — Filter, Infusion Line |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |