DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
FDA 510(k) clearance K110936 · decided 2011-06-10
Clearance details
- K-number
- K110936
- Device name
- DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
- Applicant
- AngioDynamics, Inc.
- Decision
- Unknown
- Date received
- 2011-04-04
- Decision date
- 2011-06-10
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- MSD
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Latham, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular acc recall (Z-1760-2024) | Angiodynamics, Inc. | 2024-05-03 |
| DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term recall (Z-1761-2024) | Angiodynamics, Inc. | 2024-05-03 |
| DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular a recall (Z-1762-2024) | Angiodynamics, Inc. | 2024-05-03 |
| DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular recall (Z-1763-2024) | Angiodynamics, Inc. | 2024-05-03 |
| DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular a recall (Z-1764-2024) | Angiodynamics, Inc. | 2024-05-03 |
| DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular a recall (Z-1765-2024) | Angiodynamics, Inc. | 2024-05-03 |