# K082725: Graftguard Pressure Controlling Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiovascular, LLC
- Decided: Dec 17, 2008 after 91 days
- Product code: GBX (Catheter, Irrigation)
- Device class: 1
- Regulation: 21 CFR 878.4200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000704 (2000). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043515: Graftsaver, Vescare, Inc. (2005) Summary page 1.
- K000704: DMC Saphenous Vein Distention System (SVDS), Dmc Medical, Ltd. (2000) Summary page 1.
- K853586: Pressure Sensing Syringe 65000, Dlp, Inc. (1985) Summary page 1.

## Most influential descendants
- 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
- K110993: Femchec Pressure Managemet Device (2011), 0 descendants of its own

## Recalls of this device
- Dec 22, 2022 · Class II · Z-0996-2023: Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral e

## Indications for use
The device is indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery.

Source page: https://510kreport.com/device/K082725
Methodology: https://510kreport.com/methodology