ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM
FDA 510(k) clearance K070572 · decided 2007-06-26
Clearance details
- K-number
- K070572
- Device name
- ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM
- Applicant
- Ash Access Technology, Inc.
- Decision
- Unknown
- Date received
- 2007-02-28
- Decision date
- 2007-06-26
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- MSD
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lafayette, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Centros(TM) 15F x 24cm Chronic Hemodialysis Curved Catheter Set (With Cuff 19cm From Tip), recall (Z-2396-2008) | Angiodynamics, Inc. | 2008-09-24 |
| Centros(TM) 15F x 28cm Chronic Hemodialysis Curved Catheter Set (With Cuff 23cm From Tip), recall (Z-2397-2008) | Angiodynamics, Inc. | 2008-09-24 |
| Centros(TM) 15F x 32cm Chronic Hemodialysis Curved Catheter Set (With Cuff 27cm From Tip), recall (Z-2398-2008) | Angiodynamics, Inc. | 2008-09-24 |