The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Medical Systems, Inc., Guide Wire Torque Device.
| Device ID | K072552 |
| 510k Number | K072552 |
| Device Name: | MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE |
| Classification | Wire, Guide, Catheter |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | William D Jordan |
| Correspondent | William D Jordan MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-10 |
| Decision Date | 2007-12-14 |
| Summary: | summary |