# K162064: CrossBay IVF Embryo Transfer Catheter Set

- Pathway: 510(k) (Traditional)
- Applicant: Crossbay Medical, Inc.
- Decided: Jan 5, 2017 after 163 days
- Product code: MQF (Catheter, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983594 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033084: Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter, Portex, Ltd. (2003) Summary page 4.

## Indications for use
The CrossBay IVF Embryo Transfer Catheter Set is intended for ultrasound-guided introduction of embryos into the uterine cavity following in vitro fertilization.

Source page: https://510kreport.com/device/K162064
Methodology: https://510kreport.com/methodology