K210430 is an FDA 510(k) clearance for the Intravascular Extension Set. 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 June 18, 2021, 126 days after receiving the submission on February 12, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K210430 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2021 |
| Decision Date | June 18, 2021 |
| Days to Decision | 126 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 |