The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Coronary Peripheral And Renal Steerable Guidewire.
| Device ID | K042338 |
| 510k Number | K042338 |
| Device Name: | CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Karen Mortensen |
| Correspondent | Karen Mortensen LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-30 |
| Decision Date | 2004-09-16 |
| Summary: | summary |