The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Centros Long-term Hemodialysis Catheter, Centrosflo Long-term Hemodialysis Catheter.
| Device ID | K151967 |
| 510k Number | K151967 |
| Device Name: | Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | Susan Christensen |
| Correspondent | Susan Christensen Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-16 |
| Decision Date | 2016-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450295585 | K151967 | 000 |
| 10884450276089 | K151967 | 000 |
| 10884450276126 | K151967 | 000 |
| 10884450276171 | K151967 | 000 |
| 10884450276188 | K151967 | 000 |
| 10884450276195 | K151967 | 000 |
| 10884450276201 | K151967 | 000 |
| 10884450276218 | K151967 | 000 |
| 10884450276225 | K151967 | 000 |
| 10884450276232 | K151967 | 000 |
| 10884450276249 | K151967 | 000 |
| 20884450276253 | K151967 | 000 |
| 10884450276263 | K151967 | 000 |
| 20884450276277 | K151967 | 000 |
| 10884450276287 | K151967 | 000 |
| 10884450295547 | K151967 | 000 |
| 20884450276055 | K151967 | 000 |