U9000 Plus Ultrafilter— 510(k) K211035
Substantially EquivalentBaxter Healthcare Corporation
FDA 510(k) clearance K211035 for U9000 Plus Ultrafilter, Substantially Equivalent on 2021-10-19. Applicant: Baxter Healthcare Corporation. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corporation
- Product code
- Code FIP
- Device class
- Class 2
- Regulation
- 21 CFR 876.5665
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Round Lake, IL, US
Recent devices under product code FIP
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- K243529 — Solution Administration Sets
- K242339 — Intravascular Extension Sets and Accessories
Adverse events under product code FIP
product code FIP- Malfunction
- 490
- Total
- 490
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.