GAMBRO CARTRIDGE BLOOD SETS
FDA 510(k) clearance K070414 · decided 2007-10-12
Clearance details
- K-number
- K070414
- Device name
- GAMBRO CARTRIDGE BLOOD SETS
- Applicant
- Gambro Renal Products
- Decision
- Substantially Equivalent
- Date received
- 2007-02-12
- Decision date
- 2007-10-12
- Days to decision
- 242 days
- Clearance type
- Traditional
- Product code
- FJK
- Device class
- 2
- Regulation number
- 876.5820
- 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 Set, 003410-510, is intended for single use in a hemodialysis treat recall (Z-1860-2008) | Gambro Renal Products, Inc. | 2008-09-26 |
| Gambro Cartridge Blood Set, 0141080XXXC, is intended for single use in a hemodialysis trea recall (Z-1861-2008) | Gambro Renal Products, Inc. | 2008-09-26 |