K192366 is an FDA 510(k) clearance for the Intravascular Extension Sets and Accessories. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on July 20, 2020, 325 days after receiving the submission on August 30, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K192366 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2019 |
| Decision Date | July 20, 2020 |
| Days to Decision | 325 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 |