K233975 is an FDA 510(k) clearance for the Zoom 6F Insert Catheters. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Imperative Care, Inc. (Campbell, US). The FDA issued a Cleared decision on April 2, 2024, 109 days after receiving the submission on December 15, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K233975 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2023 |
| Decision Date | April 02, 2024 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO - Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |