REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER— 510(k) K130039
Substantially EquivalentGambro Renal Products, Inc.
FDA 510(k) clearance K130039 for REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER, Substantially Equivalent on 2013-05-02. Applicant: Gambro Renal Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Gambro Renal Products, Inc.
- Product code
- Code KDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, CO, US
Recent devices under product code KDI
view allMore clearances from Gambro Renal Products, Inc.
view allAdverse events under product code KDI
product code KDI- Death
- 352
- Injury
- 1,474
- Malfunction
- 12,534
- Other
- 4
- Total
- 14,364
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K130039
K-number listed on FDA's recall record- Z-0760-2023 — Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
- Z-0762-2023 — Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
- Z-0763-2023 — Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
- Z-0764-2023 — Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
- Z-1409-2020 — Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
- Z-1908-2019 — REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
- Z-1909-2019 — REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130039.
Data sourced from openFDA. This site is unofficial and independent of the FDA.