# K052964: Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular Grafts, Woven Double Velour Woven

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jan 6, 2006 after 77 days
- Product code: DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter)
- Device class: 2
- Regulation: 21 CFR 870.3450
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K791810 (1979). 12 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955460: Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular Graft, Meadox Medicals, Div. Boston Scientific Corp. (1996) Summary page 6.
- K960766: Meadox Medicals, Inc. Expanded Ptfe Vascular Graft, Meadox Medicals, Div. Boston Scientific Corp. (1997) Summary page 6.
- K962433: Meadox Exxcel Eptfe Vascular Graft, Meadox Medicals, Div. Boston Scientific Corp. (1997) Summary page 6.
- K810845: Double Velour Grafts, Meadox Medicals, Div. Boston Scientific Corp. (1981) Summary page 6.
- K820696: Meadox Woven Double Velour, Meadox Medicals, Div. Boston Scientific Corp. (1982) Summary page 6.

## Most influential descendants
- K071778: Hero Vascular Access Device (2008), 7 descendants of its own
- K091491: Hero Vascular Access Device (2009), 6 descendants of its own
- K120006: Hero Graft (2012), 5 descendants of its own
- K121532: Hero Graft (2012), 4 descendants of its own
- K124039: Hero Graft (2013), 3 descendants of its own

## Recalls of this device
- Mar 26, 2010 · Not classified · Z-1606-2010: This is an expansion of Recall # Z-866-2010, adding an additional two lots to the recall of EXXCEL soft Stand Wall EPTFE Vascular Grafts due to a labeling mix up.
- Mar 26, 2010 · Not classified · Z-1607-2010: This is an expansion of Recall # Z-866-2010, adding an additional two lots to the recall of EXXCEL soft Stand Wall EPTFE Vascular Grafts due to a labeling mix up.
- Jan 20, 2010 · Not classified · Z-0866-2010: Labeling mix up: Shelf Carton label for Exxcel Soft Thin Wall Vascular Grafts, lot # 12633379 were mislabeled as Exxcel Soft Standard Wall Grafts. Bleeding could occur if wrong product is used.

## Indications for use
The Standard Wall ExxcelTm and Exxcel Tm Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (Iliac, Femoral, Popliteal. Infrageniculate Vessels, Axillary, Renal) and to provide vascular access. Thin Wall Exxcel Tm soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (Iliac, Femoral, Popliteal. Infrageniculate Vessels. Axillary. Renal). The Microvel Double Velour, Woven Double Velour and Cooley Veri-Soft Grafts are indicated for use in the replacement or repair of arteries affected by aneurysmal or occlusive disease (Descending Thoracic Aorta, Abdominal Aorta, Axillary, Iliac, Femoral, Popliteal, Renal).

Source page: https://510kreport.com/device/K052964
Methodology: https://510kreport.com/methodology