The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Ontrac Steerable Guidewire.
| Device ID | K941229 |
| 510k Number | K941229 |
| Device Name: | ONTRAC STEERABLE GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Carl Beaurline |
| Correspondent | Carl Beaurline LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-15 |
| Decision Date | 1994-05-12 |