REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER
FDA 510(k) clearance K130039 · decided 2013-05-02
Clearance details
- K-number
- K130039
- Device name
- REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER
- Applicant
- Gambro Renal Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-01-07
- Decision date
- 2013-05-02
- Days to decision
- 115 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failu recall (Z-0760-2023) | Baxter Healthcare Corporation | 2022-12-22 |
| Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hem recall (Z-0762-2023) | Baxter Healthcare Corporation | 2022-12-22 |
| Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hem recall (Z-0763-2023) | Baxter Healthcare Corporation | 2022-12-22 |
| Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hem recall (Z-0764-2023) | Baxter Healthcare Corporation | 2022-12-22 |