# K962433: Meadox Exxcel Eptfe Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: Meadox Medicals, Div. Boston Scientific Corp.
- Decided: Mar 17, 1997 after 266 days
- Product code: DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter)
- Device class: 2
- Regulation: 21 CFR 870.3450
- 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 K791810 (1979). 8 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K791810: Vascular Graft Prost. of Expanded Ptfe, Impra, Inc. (1979) Summary page 1.
- K955460: Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular Graft, Meadox Medicals, Div. Boston Scientific Corp. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K960766: Meadox Medicals, Inc. Expanded Ptfe Vascular Graft, Meadox Medicals, Div. Boston Scientific Corp. (1997). Our OCR of the scanned summary read K960766, which FDA decided on Mar 19, 1997, after this device was decided (Mar 17, 1997), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 1.

## Most influential descendants
- K052964: Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular Grafts, Woven Double Velour Woven (2006), 11 descendants of its own
- 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

## Indications for use
The MEADOX® EXXCEL™ ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Mid-Flex grafts are specifically indicated for vascular access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externally Supported Grafts are used where kinking and compression resistance are desired.

Source page: https://510kreport.com/device/K962433
Methodology: https://510kreport.com/methodology