510(k) K983594 ยท MQF Catheter, Assisted Reproduction
EMBRYO TRANSFER CATHETERS/SETS
| Applicant | Cook Ob/Gyn, Spencer IN, US |
| Decision | Substantially Equivalent, Dec 21, 1998 |
| Received | Oct 13, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983594
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 3, 2019 | Cook Inc. Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity. Terminated |
MQF | None listed |
| Oct 3, 2019 | Cook Inc. Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity. Terminated |
MQF | None listed |
| Dec 19, 2017 | Cook Inc. 1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24 Terminated |
MQF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.