XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170— 510(k) K093120
Substantially EquivalentBaxter Healthcare Corporation - Renal Division
FDA 510(k) clearance K093120 for XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170, Substantially Equivalent on 2010-02-17. Applicant: Baxter Healthcare Corporation - Renal Division.
Clearance details
- Applicant
- Baxter Healthcare Corporation - Renal Division
- Product code
- Code KDI
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mcgaw Park, IL, US
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.