510(k) K941381 ยท CAH Filter, Bacterial, Breathing-Circuit
HYGROBAC,S HYGROBOY AND HYGROBABY
| Applicant | Mallinckrodt Medical, Argyle NY, US |
| Decision | Substantially Equivalent, Apr 15, 1994 |
| Received | Mar 22, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941381
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2021 | Covidien, LP HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard Open, Classified |
CAH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.