The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Laureate Hydrophilic Guide Wire.
| Device ID | K092303 |
| 510k Number | K092303 |
| Device Name: | MERIT LAUREATE HYDROPHILIC GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Susan Christensen |
| Correspondent | Susan Christensen 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 | 2009-07-29 |
| Decision Date | 2009-10-27 |
| Summary: | summary |