510(k) K965016 ยท CAH Filter, Bacterial, Breathing-Circuit
ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)
| Applicant | Gibeck, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 2, 1997 |
| Received | Dec 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965016
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2022 | TELEFLEX LLC Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment. Open, Classified |
CAH | None listed |
| Oct 14, 2022 | TELEFLEX LLC Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use Open, Classified |
CAH | None listed |
| Oct 14, 2022 | TELEFLEX LLC Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use Open, Classified |
CAH | None listed |
| Oct 14, 2022 | TELEFLEX LLC Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use, Open, Classified |
CAH | None listed |
| Oct 14, 2022 | TELEFLEX LLC Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use Open, Classified |
CAH | None listed |
| Oct 14, 2022 | TELEFLEX LLC Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask) Open, Classified |
CAH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.