K182243 is an FDA 510(k) clearance for the The CVC WAND Safety Introducer with Valved Peelable Sheath. 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 September 18, 2018, 29 days after receiving the submission on August 20, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K182243 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 2018 |
| Decision Date | September 18, 2018 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB - Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |