NMI DIALYSIS CATHETER
FDA 510(k) clearance K131260 · decided 2014-02-14
Clearance details
- K-number
- K131260
- Device name
- NMI DIALYSIS CATHETER
- Applicant
- Navilyst Medical, Inc.
- Decision
- Unknown
- Date received
- 2013-05-02
- Decision date
- 2014-02-14
- Days to decision
- 288 days
- Clearance type
- Traditional
- Product code
- MSD
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H9651030 recall (Z-1579-2026) | Merit Medical Systems, Inc. | 2026-03-26 |
| BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining recall (Z-1774-2024) | Angiodynamics, Inc. | 2024-05-03 |