K140131 is an FDA 510(k) clearance for the SUB-Q SUBCUTANEOUS TISSUE INFUSION SET. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Emed Technologies Corporation (El Dorado Hills, US). The FDA issued a Cleared decision on April 3, 2014, 76 days after receiving the submission on January 17, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K140131 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2014 |
| Decision Date | April 03, 2014 |
| Days to Decision | 76 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA - Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |