K203670 is an FDA 510(k) clearance for the Extra Large Check-Flo Introducer. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on February 16, 2021, 62 days after receiving the submission on December 16, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K203670 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2020 |
| Decision Date | February 16, 2021 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB — Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |