K191909 is an FDA 510(k) clearance for the HepaShield Bacterial Viral Breathing System Filter. This device is classified as a Filter, Bacterial, Breathing-circuit (Class II - Special Controls, product code CAH).
Submitted by Flexicare Medical Limited. (Mountain Ash, GB). The FDA issued a Cleared decision on March 23, 2020, 250 days after receiving the submission on July 17, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5260.
| 510(k) Number | K191909 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 2019 |
| Decision Date | March 23, 2020 |
| Days to Decision | 250 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | CAH - Filter, Bacterial, Breathing-circuit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5260 |