The following data is part of a premarket notification filed by Lake Region Medical with the FDA for Hi Torque Connect Guidewire.
| Device ID | K112381 |
| 510k Number | K112381 |
| Device Name: | HI TORQUE CONNECT GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | LAKE REGION MEDICAL LAKE REGION MED INTL R&D CTR PARKMORE WEST BUSINESS Galway, IE Ei |
| Contact | Kenny Walsh |
| Correspondent | Kenny Walsh LAKE REGION MEDICAL LAKE REGION MED INTL R&D CTR PARKMORE WEST BUSINESS Galway, IE Ei |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-17 |
| Decision Date | 2011-11-03 |
| Summary: | summary |