# Lake Region Mfg., Inc.

- Location (FDA's records): Chaska, MN
- FDA decisions: 42 (1977–2010): 42 510(k) clearances
- Product codes: DQX (31), DQY (3), KNY (3), OCY (1), FFL (1), HSB (1), KNT (1), EZB (1)
- Predicates its devices cite: 19 (14 its own); citations of its devices by later devices: 66 (14 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Stereotaxis, Inc.: 1 (https://510kreport.com/company/stereotaxis)
- Asahi Intecc Co., Ltd.: 1 (https://510kreport.com/company/asahi-intecc)
- Guidant Corp.: 1 (https://510kreport.com/company/guidant)
- Concentric Medical, Inc.: 1 (https://510kreport.com/company/concentric-medical)

## Firms that cite its devices most
- Lake Region Medical: 10 (https://510kreport.com/company/lake-region-medical)
- Tfx Medical Group: 8 (https://510kreport.com/company/tfx-medical-group)
- Neometrics, Inc.: 3 (https://510kreport.com/company/neometrics)
- Medcomp: 3 (https://510kreport.com/company/medcomp)
- Cook, Inc.: 2 (https://510kreport.com/company/cook)
- Merit Medical Systems, Inc.: 2 (https://510kreport.com/company/merit-medical-systems)
- Cordis Corp.: 2 (https://510kreport.com/company/cordis)
- Boston Scientific Scimed, Inc.: 2 (https://510kreport.com/company/boston-scientific-scimed)

## Its most-cited devices
- K011084: Mandrel Guidewire Assembly (2001), cited by 11
- K970376: Ptca Guidewire (1997), cited by 7
- K913517: Isolate Infusion Cathetr System (1991), cited by 6
- K770977: Cardiovascular Spring Guides (1977), cited by 5
- K935170: Cardiovascular and Vascular Guidewire Modifications (1994), cited by 4
- K011968: Streerable Ptca Guidewire (2001), cited by 4

## Recent decisions
- K092965: Trailrunner Guidewires (Feb 26, 2010)
- K082922: Freeway and Railrunner Guidewires (Dec 9, 2008)
- K081708: Taxi Endoscopic Guidewire (Aug 26, 2008)
- K080144: Mandrel Guidewires or M-Wires (Feb 26, 2008)
- K073655: Pegasus Steerable (Ptca) Guidewire (Jan 28, 2008)
- K060454: Titan Guidewire (Mar 24, 2006)
- K052347: Titan Steerable (Ptca) Guidewire (Feb 17, 2006)
- K042338: Coronary Peripheral and Renal Steerable Guidewire (Sep 16, 2004)

Source page: https://510kreport.com/company/lake-region-mfg