K193034 is an FDA 510(k) clearance for the AXS Infinity LS Plus Long Sheath. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Stryker Neurovascular (Fremont, US). The FDA issued a Cleared decision on November 29, 2019, 29 days after receiving the submission on October 31, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K193034 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2019 |
| Decision Date | November 29, 2019 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |