# Boston Scientific Corp

- Location (FDA's records): Maple Grove, MN
- FDA decisions: 809 (1981–2026): 732 510(k) clearances, 2 De Novo grants and 75 original PMA approvals
- Names in FDA's records: Boston Scientific Corp (468); Boston Scientific Corporation (256); Boston Scientific (82); Boston Scientific Limited (1); Boston Scientific Corporation - (1); Boston Scientific, Inc. (1)
- Product codes: FGE (56), LIT (52), DQX (34), DQY (30), DQO (20), KNS (18), DYB (16), KRD (16), DQK (15), ESW (15), GEI (15), DRF (14)
- 510(k) review time since 2016: median 69 days, against 113 for FDA's reviews in the same codes and years (102 of 149 faster)
- Predicates its devices cite: 783 (488 its own); citations of its devices by later devices: 969 (488 its own)
- Recalls linked to its devices: 888 (103 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Scimed, Inc.: 24 (https://510kreport.com/company/boston-scientific-scimed)
- Scimed Life Systems, Inc.: 15 (https://510kreport.com/company/scimed-life-systems)
- Boston Scientific, Target: 13 (https://510kreport.com/company/boston-scientific-target)
- Meadox Medicals, Div. Boston Scientific Corp.: 9 (https://510kreport.com/company/meadox-medicals-div-boston-scientific)
- Olympus Medical Systems Corp.: 8 (https://510kreport.com/company/olympus-medical-systems)
- Olympus America, Inc.: 8 (https://510kreport.com/company/olympus-america)
- Target Therapeutics: 7 (https://510kreport.com/company/target-therapeutics)
- Guidant Corp.: 6 (https://510kreport.com/company/guidant)

## Firms that cite its devices most
- Navilyst Medical, Inc.: 17 (https://510kreport.com/company/navilyst-medical)
- Cook, Inc.: 17 (https://510kreport.com/company/cook)
- Micro-Tech (Nanjing) Co., Ltd.: 10 (https://510kreport.com/company/micro-tech-nanjing)
- Cook Ireland, Ltd.: 9 (https://510kreport.com/company/cook-ireland)
- Asahi Intecc Co., Ltd.: 9 (https://510kreport.com/company/asahi-intecc)
- Stryker Neurovascular: 9 (https://510kreport.com/company/stryker-neurovascular)
- Taewoong Medical Co., Ltd.: 9 (https://510kreport.com/company/taewoong-medical)
- Olympus Medical Systems Corp.: 8 (https://510kreport.com/company/olympus-medical-systems)

## Its most-cited devices
- K103751: Mustang Balloon Dilatation Catheters (2011), cited by 10
- K112994: Cre Ditatation Ballon (2012), cited by 10
- K963241: Ultraflex (1996), cited by 9
- K053118: Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx (2005), cited by 9
- K013153: Autotome RX Model # 4515, 4516 (2001), cited by 9
- K971254: Transend EX Platinum Guidewire (1997), cited by 9

## Recent decisions
- K262151: SpaceOAR Flex™ System (Sep 11, 2026)
- K262460: Rezum System (Sep 3, 2026)
- K261153: LithoVue Elite Digital Flexible Ureteroscope System (Aug 26, 2026)
- K253692: AVVIGO™+ Multi-Modality Guidance System (Aug 21, 2026)
- K262406: EluPro Antibiotic-Eluting BioEnvelope (Aug 12, 2026)
- K261915: Navigator™ Flex Ureteral Access Sheath Set (Aug 4, 2026)
- K262462: TheraSphere 360™ Y-90 Management Platform (Jul 24, 2026)
- K262165: FARADRIVE™ Steerable Sheath (M004PF21M402) (Jul 24, 2026)

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