510(k) K983590 ยท MQF Catheter, Assisted Reproduction
GIFT CATHETER SET/S
| 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 K983590
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2017 | Cook Inc. Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022
Product Usage:
Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for o Terminated |
MQF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.