510(k) K122078 ยท EZD Catheter, Straight
LOFRIC PRIMO, LOFRIC HYDRO-KIT
| Applicant | Astra Tech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 31, 2012 |
| Received | Jul 16, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122078
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 17, 2020 | Wellspect HealthCare (Division of DENTSPLY IH AB) LoFric Origo, Nelaton, 16in, FR10 urinary catheters Terminated |
EZD | None listed |
| Jun 17, 2020 | Wellspect HealthCare (Division of DENTSPLY IH AB) LoFric Origo, Tiemann, 16in, FR12 urinary catheters Terminated |
EZD | None listed |
| Jun 17, 2020 | Wellspect HealthCare (Division of DENTSPLY IH AB) LoFric Origo, Tiemann, 16in, FR14 urinary catheters Terminated |
EZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.