Heater-Cooler System 3T— 510(k) K191402
Substantially EquivalentLivanova Deutschland, GmbH
FDA 510(k) clearance K191402 for Heater-Cooler System 3T, Substantially Equivalent on 2020-02-25. Applicant: Livanova Deutschland, GmbH. Device class: 2.
Clearance details
- Applicant
- Livanova Deutschland, GmbH
- Product code
- Code DWC
- Device class
- Class 2
- Regulation
- 21 CFR 870.4250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Munich, DE
Recent devices under product code DWC
view allMore clearances from Livanova Deutschland, GmbH
view allAdverse events under product code DWC
product code DWC- Death
- 124
- Injury
- 233
- Malfunction
- 3,727
- Total
- 4,084
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 K191402
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 K191402.
Data sourced from openFDA. This site is unofficial and independent of the FDA.