PRISMA SYSTEM R03.10A— 510(k) K062090
Substantially EquivalentGambro Renal Products
FDA 510(k) clearance K062090 for PRISMA SYSTEM R03.10A, Substantially Equivalent on 2006-10-18. 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
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- K072908 — PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY
- K070414 — GAMBRO CARTRIDGE BLOOD SETS
- K063290 — GAMBRO QUICKSET BLOODLINES
- K060195 — GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.