The following data is part of a premarket notification filed by Lake Region Medical with the FDA for Hi Torque Connect Guidewire, Hi Torque Connect Flex Guidewire, Hi Torque Connect 250t Guidewire.
| Device ID | K140536 |
| 510k Number | K140536 |
| Device Name: | HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | LAKE REGION MEDICAL LAKE REGION MED INTL R&D CTR PARKMORE WEST BUSINESS Galway, IE Ireland |
| Contact | Kenneth Walsh |
| Correspondent | Kenneth Walsh LAKE REGION MEDICAL LAKE REGION MED INTL R&D CTR PARKMORE WEST BUSINESS Galway, IE Ireland |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-04 |
| Decision Date | 2014-12-17 |
| Summary: | summary |