# K043515: Graftsaver

- Pathway: 510(k) (Traditional)
- Applicant: Vescare, Inc.
- Decided: Mar 31, 2005 after 101 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: 1 generation back to K000704 (2000). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 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) Summary page 1.

## Most influential descendants
- K082725: Graftguard Pressure Controlling Syringe (2008), 5 descendants of its own
- K091733: Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500 (2009), 2 descendants of its own
- K191947: VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord (2019), 0 descendants of its own
- K140603: Onepass Endoscopic Vessel Harvesting Sysyetm (2014), 0 descendants of its own
- K131659: Moerae Vein Preparation Kit (2014), 0 descendants of its own

## Indications for use
The device is indicated for use in the distention and irrigation of venous vessels prior to use as a bspass graft.

Source page: https://510kreport.com/device/K043515
Methodology: https://510kreport.com/methodology