K220280 is an FDA 510(k) clearance for the Arrow Stiffening Stylet. This device is classified as a Stylet, Catheter (Class II - Special Controls, product code DRB).
Submitted by Arrow International, LLC (A subsidiary of Teleflex, Inc.) (Morrisville, US). The FDA issued a Cleared decision on August 30, 2022, 210 days after receiving the submission on February 1, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1380.
| 510(k) Number | K220280 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2022 |
| Decision Date | August 30, 2022 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRB - Stylet, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1380 |