K222185 is an FDA 510(k) clearance for the Stratus Infusion Catheter. This device is classified as a Catheter, Infusion, Syringe (Class II - Special Controls, product code NPG).
Submitted by Intervene, Inc. (South San Francisco, US). The FDA issued a Cleared decision on April 13, 2023, 265 days after receiving the submission on July 22, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210. To Provide Physician Specified Fluids Both Perivascular Or Intraluminal To The Perivascular Space..
| 510(k) Number | K222185 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2022 |
| Decision Date | April 13, 2023 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | NPG - Catheter, Infusion, Syringe |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1210 |
| Definition | To Provide Physician Specified Fluids Both Perivascular Or Intraluminal To The Perivascular Space. |