# Boston Scientific Scimed, Inc.

- Location (FDA's records): Plymouth, MN
- FDA decisions: 40 (1994–2005): 35 510(k) clearances and 5 original PMA approvals
- Product codes: JCT (9), FGE (7), DQO (5), DQY (5), MAF (4), ESW (2), LIT (2), NIO (1), DYG (1), MUM (1), MQR (1), OBJ (1)
- Predicates its devices cite: 49 (26 its own); citations of its devices by later devices: 63 (26 its own)
- Recalls linked to its devices: 62 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Schneider U.S. Stent Div.: 6 (https://510kreport.com/company/schneider-us-stent-div)
- Boston Scientific Corp: 4 (https://510kreport.com/company/boston-scientific)
- Guidant Corp.: 4 (https://510kreport.com/company/guidant)
- Pfizer Hospital Products Group, Inc.: 2 (https://510kreport.com/company/pfizer-hospital-products-group)
- Schneider Intl., Ltd.: 2 (https://510kreport.com/company/schneider-intl)
- Lake Region Mfg., Inc.: 2 (https://510kreport.com/company/lake-region-mfg)
- North American Instrument Corp.: 1 (https://510kreport.com/company/north-american-instrument)
- Cordis Corp.: 1 (https://510kreport.com/company/cordis)

## Firms that cite its devices most
- Boston Scientific Corp: 24 (https://510kreport.com/company/boston-scientific)
- Cordis Corp.: 3 (https://510kreport.com/company/cordis)
- Medinol, Ltd.: 2 (https://510kreport.com/company/medinol)
- Stryker Neurovascular: 1 (https://510kreport.com/company/stryker-neurovascular)
- Cardiosolutions, Inc.: 1 (https://510kreport.com/company/cardiosolutions)
- Intratherapeutics, Inc.: 1 (https://510kreport.com/company/intratherapeutics)
- Schneider (Europe) GmbH: 1 (https://510kreport.com/company/schneider-europe)
- Asahi Intecc Co., Ltd.: 1 (https://510kreport.com/company/asahi-intecc)

## Its most-cited devices
- K964119: Wallstent Transhepatic Biliary Endoprosthesis (1997), cited by 8
- K934116: Wallstent Tracheobronchial Prosthesis Modification (1994), cited by 6
- K961262: Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary Endoprosthesis (1996), cited by 6
- K993232: Wallstent Biliary Endoprosthesis and Unistep Plus Delivery System (1999), cited by 4
- K030617: PT2 Guide Wire and Addwire Extension Wire (2003), cited by 4
- K982184: Wallstent Endoprosthesis (1998), cited by 3

## Recent decisions
- P040016: Veriflex (Liberte) Bare-Metal Coronary Stent System (Apr 12, 2005)
- K041727: Modification to Atlantis PV Imaging Catheter, Model 36456 (Jul 23, 2004)
- K030617: PT2 Guide Wire and Addwire Extension Wire (May 21, 2003)
- K024048: Modification to Boston Scientific Express Biliary LD Premounted Stent System (Jan 6, 2003)
- P020009: Express/Express 2 MR & Otw Coronary Stent Systems (Sep 11, 2002)
- K021735: Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter (Aug 8, 2002)
- K021901: Wallgraft Tracheobronchial Endoprothesis with Unistep Plus Delivery System (Jul 9, 2002)
- K012822: Modificiation to: Biliary Wallstent Endoprostheis with Monorail Delivery System, Model 71-XXX (Oct 24, 2001)

Source page: https://510kreport.com/company/boston-scientific-scimed