Lake Region Mfg., Inc.
Chaska, MN, US
Lake Region Mfg., Inc. appears in FDA device records in Chaska, MN. FDA records list 42 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 42
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 42 510(k) clearances for Lake Region Mfg., Inc. between 1977 and 2010. The busiest year on record is 1991, with 6. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1985 | 3 |
| 1986 | 2 |
| 1987 | 2 |
| 1990 | 1 |
| 1991 | 6 |
| 1992 | 1 |
| 1994 | 3 |
| 1996 | 2 |
| 1997 | 2 |
| 1998 | 3 |
| 2000 | 2 |
| 2001 | 2 |
| 2003 | 2 |
| 2004 | 3 |
| 2006 | 2 |
| 2008 | 4 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K092965 | TRAILRUNNER GUIDEWIRES | DQX | Substantially Equivalent | |
| K082922 | FREEWAY AND RAILRUNNER GUIDEWIRES | DQX | Substantially Equivalent | |
| K081708 | TAXI ENDOSCOPIC GUIDEWIRE | OCY | Substantially Equivalent | |
| K080144 | MANDREL GUIDEWIRES OR M-WIRES | DQX | Substantially Equivalent | |
| K073655 | PEGASUS STEERABLE (PTCA) GUIDEWIRE | DQX | Substantially Equivalent | |
| K060454 | TITAN GUIDEWIRE | DQX | Substantially Equivalent | |
| K052347 | TITAN STEERABLE (PTCA) GUIDEWIRE | DQX | Substantially Equivalent | |
| K042338 | CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE | DQX | Substantially Equivalent | |
| K041624 | PTCA STEERABLE HYDROPHILIC GUIDEWIRE | DQX | Substantially Equivalent | |
| K040825 | LAKE REGION HYDROPHILIC GUIDEWIRE | DQX | Substantially Equivalent | |
| K033758 | HYDROPHILIC GUIDEWIRE | DQX | Substantially Equivalent | |
| K022813 | STEERABLE GUIDEWIRE | DQX | Substantially Equivalent | |
| K011968 | STREERABLE PTCA GUIDEWIRE | DQX | Substantially Equivalent | |
| K011084 | MANDREL GUIDEWIRE ASSEMBLY | DQX | Substantially Equivalent | |
| K003483 | MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE) | DQX | Substantially Equivalent | |
| K000011 | MODIFIED HYDROPHILIC COATED GUIDEWIRE | DQX | Substantially Equivalent | |
| K971322 | CORE AND COIL ASSEMBLY GUIDEWIRE | DQX | Substantially Equivalent | |
| K981326 | LAKE REGION MANUFACTURING GUIDEWIRES | DQX | Substantially Equivalent | |
| K981667 | HYDROPHILIC COATED GUIDEWIRE | KNY | Substantially Equivalent | |
| K970376 | PTCA GUIDEWIRE | DQX | Substantially Equivalent | |
| K970994 | CORE AND COIL ASSEMBLY GUIDEWIRE | EZB | Substantially Equivalent | |
| K960718 | LRM | DQX | Substantially Equivalent | |
| K960866 | LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS. | KNY | Substantially Equivalent | |
| K935198 | GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS | KNT | Substantially Equivalent | |
| K941229 | ONTRAC STEERABLE GUIDEWIRE | DQX | Substantially Equivalent | |
| K935170 | CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS | DQX | Substantially Equivalent | |
| K921200 | GUIDEWIRE | KNY | Substantially Equivalent | |
| K914138 | ONTRAC | DQX | Substantially Equivalent | |
| K913517 | ISOLATE INFUSION CATHETR SYSTEM | DQY | Substantially Equivalent | |
| K912877 | PROFUSE INFUSION SYSTEM | DQY | Substantially Equivalent | |
| K912878 | OPEN ENDED GUIDEWIRE | DQX | Substantially Equivalent | |
| K905639 | TORQUE HANDLE DEVICE FOR GUIDEWIRE | DQX | Substantially Equivalent | |
| K905581 | SILICONE COATED GUIDEWIRES | DQX | Substantially Equivalent | |
| K901224 | INSITE STEERABLE GUIDEWIRE | DQX | Substantially Equivalent | |
| K871882 | LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW) | DQX | Substantially Equivalent | |
| K864058 | AMPLATZ MOVEABLE CORE GUIDEWIRE | DQX | Substantially Equivalent | |
| K861469 | DUTHOY STONE BASKET | FFL | Substantially Equivalent | |
| K861365 | FASICULATED NAIL | HSB | Substantially Equivalent | |
| K850829 | WIRE, GUIDE, CATHETER | DQY | Substantially Equivalent | |
| K850828 | WIRE, GUIDE - MODIFICATION | DQX | Substantially Equivalent | |
| K850827 | GUIDE, WIRE, ANGIOGRAPHIC | DQX | Substantially Equivalent | |
| K770977 | CARDIOVASCULAR SPRING GUIDES | DQX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNYAccessories, Catheter, G-U
- DQYCatheter, Percutaneous
- FFLDislodger, Stone, Basket, Ureteral, Metal
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- HSBRod, Fixation, Intramedullary And Accessories
- EZBStylet For Catheter, Gastro-Urology
- KNTTubes, Gastrointestinal (And Accessories)
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain