PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET
FDA 510(k) clearance K001156 · decided 2000-07-07
Clearance details
- K-number
- K001156
- Device name
- PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET
- Applicant
- Gambro Renal Products
- Decision
- Substantially Equivalent
- Date received
- 2000-04-10
- Decision date
- 2000-07-07
- Days to decision
- 88 days
- Clearance type
- Abbreviated
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lakewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 ( recall (Z-1367-2008) | Gambro Renal Products, Inc. | 2008-03-25 |
| Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Ga recall (Z-0200-2007) | Gambro Renal Products, Inc. | 2006-11-21 |