K200289 is an FDA 510(k) clearance for the Michler-Kapp Cardiovascular Vent Catheter. This device is classified as a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II - Special Controls, product code DWF).
Submitted by Kapp Surgical Instrument, Inc. (Warrensville, US). The FDA issued a Cleared decision on January 28, 2021, 358 days after receiving the submission on February 5, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4210.
| 510(k) Number | K200289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2020 |
| Decision Date | January 28, 2021 |
| Days to Decision | 358 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWF - Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4210 |