Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter
FDA 510(k) clearance K151967 · decided 2016-04-04
Clearance details
- K-number
- K151967
- Device name
- Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter
- Applicant
- Merit Medical Systems, Inc.
- Decision
- Unknown
- Date received
- 2015-07-16
- Decision date
- 2016-04-04
- Days to decision
- 263 days
- Clearance type
- Traditional
- Product code
- MSD
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- South Jordan, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CE recall (Z-1575-2026) | Merit Medical Systems, Inc. | 2026-03-26 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023/S005) | Merit Medical Systems, Inc. | 2026-06-11 |
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023/S004) | Merit Medical Systems, Inc. | 2025-12-11 |
| WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S001) | Merit Medical Systems, Inc. | 2025-02-12 |
| WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S002) | Merit Medical Systems, Inc. | 2025-02-12 |
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023) | Merit Medical Systems, Inc. | 2024-12-19 |