K202672 is an FDA 510(k) clearance for the Precision Delivery Infusion Set. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Quest Medical, Inc. (Allen, US). The FDA issued a Cleared decision on January 21, 2021, 128 days after receiving the submission on September 15, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K202672 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2020 |
| Decision Date | January 21, 2021 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| 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 |