K223258 is an FDA 510(k) clearance for the TNI Clear-Guard™ 3 angled breathing filter (1545020). This device is classified as a Filter, Bacterial, Breathing-circuit (Class II - Special Controls, product code CAH).
Submitted by Intersurgical , Ltd. (Berkshire, GB). The FDA issued a Cleared decision on June 15, 2023, 237 days after receiving the submission on October 21, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5260.
| 510(k) Number | K223258 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 2022 |
| Decision Date | June 15, 2023 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | CAH - Filter, Bacterial, Breathing-circuit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5260 |