Submission Details
| 510(k) Number | K191909 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
HepaShield Bacterial Viral Breathing System Filter
Mar 2020
Decision
250d
Days
Class 2
Risk
About This 510(k) Submission
K191909 is an FDA 510(k) clearance for the HepaShield Bacterial Viral Breathing System Filter, 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 review panel. Regulated under 21 CFR 868.5260.
Device Classification
| Product Code | CAH — Filter, Bacterial, Breathing-circuit |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5260 |
Manufacturer
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