XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210— 510(k) K083778
Substantially EquivalentBaxter Healthcare Corporation
FDA 510(k) clearance K083778 for XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210, Substantially Equivalent on 2009-02-20. Applicant: Baxter Healthcare Corporation. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corporation
- 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
- Special
- Location
- Mcgaw Park, IL, US
Recent devices under product code KDI
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- K242339 — Intravascular Extension Sets and Accessories
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.