Access Scientific, LLC · Class II · Cleared Jul 25, 2019
| K-number | K183066 |
| Device name | The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD Technology-3 Fr, 4 Fr, and 5 Fr Model |
| Applicant | Access Scientific, LLC |
| Product code | DYB |
| Device class | Class II |
| Decision date | Jul 25, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 870.1340 |
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