ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT
FDA 510(k) clearance K080400 · decided 2008-05-13
Clearance details
- K-number
- K080400
- Device name
- ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT
- Applicant
- AngioDynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-02-13
- Decision date
- 2008-05-13
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MSD
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Queensburgy, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DURAMAX 15.5 F x 22 cm Chronic Hemodialysis Catheter Set (With Cuff 17 cm from Tip), DuraM recall (Z-0586-2012) | Angiodynamics, Inc. | 2012-01-11 |
| DURAMAX 15.5 F x 24 cm Chronic Hemodialysis Catheter Set (With Cuff 19 cm from Tip), DuraM recall (Z-0587-2012) | Angiodynamics, Inc. | 2012-01-11 |
| DURAMAX 15.5 F x 28 cm Chronic Hemodialysis Catheter Set (With Cuff 23 cm from Tip), DuraM recall (Z-0588-2012) | Angiodynamics, Inc. | 2012-01-11 |
| DURAMAX 15.5 F x 32 cm Chronic Hemodialysis Catheter Set (With Cuff 27 cm from Tip), DuraM recall (Z-0589-2012) | Angiodynamics, Inc. | 2012-01-11 |
| DURAMAX 15.5 F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31 cm from Tip), DuraM recall (Z-0590-2012) | Angiodynamics, Inc. | 2012-01-11 |