Company ยท US
Lake Region Mfg., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2010. Name variants (Inc, Corp, punctuation) are merged.
42510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQX | Wire, Guide, Catheter | 31 |
| DQY | Catheter, Percutaneous | 3 |
| KNY | Accessories, Catheter, G-U | 3 |
| EZB | Stylet For Catheter, Gastro-Urology | 1 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 26, 2010 | K092965 | TRAILRUNNER GUIDEWIRES Lake Region Mfg., Inc. | DQX |
| Dec 9, 2008 | K082922 | FREEWAY AND RAILRUNNER GUIDEWIRES Lake Region Mfg., Inc. | DQX |
| Aug 26, 2008 | K081708 | TAXI ENDOSCOPIC GUIDEWIRE Lake Region Mfg., Inc. | OCY |
| Feb 26, 2008 | K080144 | MANDREL GUIDEWIRES OR M-WIRES Lake Region Mfg., Inc. | DQX |
| Jan 28, 2008 | K073655 | PEGASUS STEERABLE (PTCA) GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| Mar 24, 2006 | K060454 | TITAN GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| Feb 17, 2006 | K052347 | TITAN STEERABLE (PTCA) GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| Sep 16, 2004 | K042338 | CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| Jul 16, 2004 | K041624 | PTCA STEERABLE HYDROPHILIC GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| May 17, 2004 | K040825 | LAKE REGION HYDROPHILIC GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| Dec 19, 2003 | K033758 | HYDROPHILIC GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| Feb 14, 2003 | K022813 | STEERABLE GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| Jul 25, 2001 | K011968 | STREERABLE PTCA GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| May 10, 2001 | K011084 | MANDREL GUIDEWIRE ASSEMBLY Lake Region Mfg., Inc. | DQX |
| Dec 6, 2000 | K003483 | MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE) Lake Region Mfg., Inc. | DQX |
| Mar 1, 2000 | K000011 | MODIFIED HYDROPHILIC COATED GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| Jul 22, 1998 | K971322 | CORE AND COIL ASSEMBLY GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| Jul 10, 1998 | K981326 | LAKE REGION MANUFACTURING GUIDEWIRES Lake Region Mfg., Inc. | DQX |
| Jun 5, 1998 | K981667 | HYDROPHILIC COATED GUIDEWIRE Lake Region Mfg., Inc. | KNY |
| Jun 6, 1997 | K970376 | PTCA GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| Mar 25, 1997 | K970994 | CORE AND COIL ASSEMBLY GUIDEWIRE Lake Region Mfg., Inc. | EZB |
| May 21, 1996 | K960718 | LRM Lake Region Mfg., Inc. | DQX |
| Apr 5, 1996 | K960866 | LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS. Lake Region Mfg., Inc. | KNY |
| Sep 28, 1994 | K935198 | GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS Lake Region Mfg., Inc. | KNT |
| May 12, 1994 | K941229 | ONTRAC STEERABLE GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| Mar 31, 1994 | K935170 | CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS Lake Region Mfg., Inc. | DQX |
| Sep 4, 1992 | K921200 | GUIDEWIRE Lake Region Mfg., Inc. | KNY |
| Dec 13, 1991 | K914138 | ONTRAC Lake Region Mfg., Inc. | DQX |
| Nov 5, 1991 | K913517 | ISOLATE INFUSION CATHETR SYSTEM Lake Region Mfg., Inc. | DQY |
| Sep 23, 1991 | K912877 | PROFUSE INFUSION SYSTEM Lake Region Mfg., Inc. | DQY |
| Sep 11, 1991 | K912878 | OPEN ENDED GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| Feb 20, 1991 | K905639 | TORQUE HANDLE DEVICE FOR GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| Feb 19, 1991 | K905581 | SILICONE COATED GUIDEWIRES Lake Region Mfg., Inc. | DQX |
| Jun 11, 1990 | K901224 | INSITE STEERABLE GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| Sep 15, 1987 | K871882 | LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW) Lake Region Mfg., Inc. | DQX |
| Feb 19, 1987 | K864058 | AMPLATZ MOVEABLE CORE GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| May 15, 1986 | K861469 | DUTHOY STONE BASKET Lake Region Mfg., Inc. | FFL |
| May 6, 1986 | K861365 | FASICULATED NAIL Lake Region Mfg., Inc. | HSB |
| Jun 26, 1985 | K850829 | WIRE, GUIDE, CATHETER Lake Region Mfg., Inc. | DQY |
| Jun 26, 1985 | K850828 | WIRE, GUIDE - MODIFICATION Lake Region Mfg., Inc. | DQX |
| Jun 26, 1985 | K850827 | GUIDE, WIRE, ANGIOGRAPHIC Lake Region Mfg., Inc. | DQX |
| Jun 14, 1977 | K770977 | CARDIOVASCULAR SPRING GUIDES Lake Region Mfg., Inc. | DQX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||