CATSmart— 510(k) K180831
Substantially EquivalentFresenius Kabi AG
FDA 510(k) clearance K180831 for CATSmart, Substantially Equivalent on 2018-12-10. Applicant: Fresenius Kabi AG. Device class: 2.
Clearance details
- Applicant
- Fresenius Kabi AG
- Product code
- Code CAC
- Device class
- Class 2
- Regulation
- 21 CFR 868.5830
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bad Homburg, DE
Recent devices under product code CAC
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view all- K251139 — KabiHelp® Uno; KabiHelp® Advance plus
- K212445 — freeflex+ Transfer Adapter
- K210073 — Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo
- K210074 — Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable
- K210075 — Vigilant Software Suite Vigilant Master Med
Adverse events under product code CAC
product code CAC- Death
- 11
- Malfunction
- 477
- Total
- 488
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 K180831
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180831.
Data sourced from openFDA. This site is unofficial and independent of the FDA.