# Meadox Medicals, Div. Boston Scientific Corp.

- Location (FDA's records): Oakland, NJ
- FDA decisions: 54 (1976–1997): 53 510(k) clearances and 1 original PMA approval
- Product codes: DSY (15), LIT (14), DQX (5), DXZ (5), EZN (3), FTL (2), DPW (1), FGE (1), KNW (1), DYF (1), KDC (1), LJE (1)
- Predicates its devices cite: 22 (5 its own); citations of its devices by later devices: 27 (5 its own)
- Recalls linked to its devices: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- W. L. Gore & Associates, Inc.: 9 (https://510kreport.com/company/w-l-gore-associates)
- Impra, Inc.: 3 (https://510kreport.com/company/impra)
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)
- Baxter Healthcare Corp: 2 (https://510kreport.com/company/baxter-healthcare)
- Maquet Cardiovascular, LLC: 1 (https://510kreport.com/company/maquet-cardiovascular)

## Firms that cite its devices most
- Boston Scientific Corp: 9 (https://510kreport.com/company/boston-scientific)
- Maquet Cardiovascular, LLC: 2 (https://510kreport.com/company/maquet-cardiovascular)
- LeMaitre Vascular, Inc.: 2 (https://510kreport.com/company/lemaitre-vascular)
- Vascutek, Ltd.: 1 (https://510kreport.com/company/vascutek)
- Sunwei Tech Co., Ltd.: 1 (https://510kreport.com/company/sunwei-tech)
- Carbomedics, Inc.: 1 (https://510kreport.com/company/carbomedics)
- Shelhigh, Inc.: 1 (https://510kreport.com/company/shelhigh)
- Vascular Control Systems, Inc.: 1 (https://510kreport.com/company/vascular-control-systems)

## Its most-cited devices
- K962433: Meadox Exxcel Eptfe Vascular Graft (1997), cited by 3
- K930622: Amplatz Guidewires (1993), cited by 2
- K962342: Hemashield Finesse Ultra-Thin, Knitted Cardiovascular Patch (1996), cited by 2
- K955460: Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular Graft (1996), cited by 2
- K954848: Hemashield Microvel Velour Knitted Vascular Graft (1996), cited by 2
- K854431: Meadox Medicals Inc. Graft Sizer (1986), cited by 2

## Recent decisions
- K953647: MS Classique Balloon Catheter W/Hydropass Coating (May 16, 1997)
- K960766: Meadox Medicals, Inc. Expanded Ptfe Vascular Graft (Mar 19, 1997)
- K962433: Meadox Exxcel Eptfe Vascular Graft (Mar 17, 1997)
- K961847: Hemashield Vantage (Vascular Graft (Jan 22, 1997)
- K962342: Hemashield Finesse Ultra-Thin, Knitted Cardiovascular Patch (Sep 10, 1996)
- K955460: Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular Graft (May 30, 1996)
- K952884: Noprofile Olbert Catheter System Balloon Dilatation Catheter (Feb 21, 1996)
- K955349: Hemashield Knitted Double Velour Cardiovascular Fabric (Feb 14, 1996)

Source page: https://510kreport.com/company/meadox-medicals-div-boston-scientific