VENOUS DRAINAGE CANNULA WITH DURAFLO COATING— 510(k) K120072
Substantially EquivalentEdwards Lifesciences, LLC
FDA 510(k) clearance K120072 for VENOUS DRAINAGE CANNULA WITH DURAFLO COATING, Substantially Equivalent on 2012-05-08. Applicant: Edwards Lifesciences, LLC. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciences, LLC
- Product code
- Code DWF
- Device class
- Class 2
- Regulation
- 21 CFR 870.4210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Draper, UT, US
Recent devices under product code DWF
view allMore clearances from Edwards Lifesciences, LLC
view allAdverse events under product code DWF
product code DWF- Death
- 106
- Injury
- 386
- Malfunction
- 2,323
- Total
- 2,815
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 K120072
K-number listed on FDA's recall record- Z-3029-2018 — Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.
- Z-3030-2018 — Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.
- Z-3031-2018 — Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.
- Z-0398-2016 — Thin-Flex Venous Cannula, Model Number:TF292902A
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120072.
Data sourced from openFDA. This site is unofficial and independent of the FDA.