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 | K141363 |
| 510k Number | K141363 |
| Device Name: | CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS 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 - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-23 |
| Decision Date | 2014-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450256418 | K141363 | 000 |
| 10884450242015 | K141363 | 000 |
| 10884450200060 | K141363 | 000 |
| 10884450200053 | K141363 | 000 |
| 10884450200022 | K141363 | 000 |
| 10884450200015 | K141363 | 000 |
| 10884450200008 | K141363 | 000 |
| 10884450199999 | K141363 | 000 |
| 20884450199972 | K141363 | 000 |
| 20884450199958 | K141363 | 000 |
| 20884450199910 | K141363 | 000 |
| 20884450199903 | K141363 | 000 |
| 20884450199880 | K141363 | 000 |
| 10884450242022 | K141363 | 000 |
| 10884450242039 | K141363 | 000 |
| 10884450256401 | K141363 | 000 |
| 10884450256395 | K141363 | 000 |
| 10884450256340 | K141363 | 000 |
| 10884450242121 | K141363 | 000 |
| 10884450242114 | K141363 | 000 |
| 10884450242107 | K141363 | 000 |
| 10884450242091 | K141363 | 000 |
| 10884450242084 | K141363 | 000 |
| 10884450242077 | K141363 | 000 |
| 20884450242067 | K141363 | 000 |
| 20884450242050 | K141363 | 000 |
| 20884450242043 | K141363 | 000 |
| 10884450190439 | K141363 | 000 |