# K131659: Moerae Vein Preparation Kit

- Pathway: 510(k) (Traditional)
- Applicant: Moerae Matrix, Inc.
- Decided: Mar 3, 2014 after 270 days
- Product code: GBX (Catheter, Irrigation)
- Device class: 1
- Regulation: 21 CFR 878.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000704 (2000). 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)
- K000704: DMC Saphenous Vein Distention System (SVDS), Dmc Medical, Ltd. (2000). Our reading of the summary gave K000104, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “OMG Saphenous Vein Distension System”.
- K082725: Graftguard Pressure Controlling Syringe, Maquet Cardiovascular, LLC (2008) Summary page 1.

## Indications for use
The VasoPrep Vein Preparation Kit is a sterilized convenience kit indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery.

Source page: https://510kreport.com/device/K131659
Methodology: https://510kreport.com/methodology