K181563 is an FDA 510(k) clearance for the The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Access Scientific, LLC (San Diego, US). The FDA issued a Cleared decision on September 26, 2018, 104 days after receiving the submission on June 14, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K181563 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2018 |
| Decision Date | September 26, 2018 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY - Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |