K221518 is an FDA 510(k) clearance for the NP Medical nCompass Extension Set with Stabilizing Base. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Np Medical (Clinton, US). The FDA issued a Cleared decision on November 3, 2022, 162 days after receiving the submission on May 25, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K221518 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 2022 |
| Decision Date | November 03, 2022 |
| Days to Decision | 162 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 |