The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Proguide Chronic Dialysis Catheter.
| Device ID | K090148 |
| 510k Number | K090148 |
| Device Name: | PROGUIDE CHRONIC DIALYSIS CATHETER |
| Classification | Catheter, Hemodialysis, Implanted |
| 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 | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-21 |
| Decision Date | 2009-04-13 |
| Summary: | summary |