K183066 is an FDA 510(k) clearance for the The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Access Scientific, LLC (San Diego, US). The FDA issued a Cleared decision on July 25, 2019, 262 days after receiving the submission on November 5, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K183066 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2018 |
| Decision Date | July 25, 2019 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB - Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |