GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE— 510(k) K060195
Substantially EquivalentGambro Renal Products
FDA 510(k) clearance K060195 for GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE, Substantially Equivalent on 2006-04-24. Applicant: Gambro Renal Products. Device class: 2.
Clearance details
- Applicant
- Gambro Renal Products
- 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
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 K060195
K-number listed on FDA's recall record- Z-0370-2017 — GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.
- Z-1644-2014 — Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060195.
Data sourced from openFDA. This site is unofficial and independent of the FDA.