IntraClude Intra-Aortic Occlusion Device— 510(k) K163693
Substantially EquivalentEdwards Lifesciences, LLC
FDA 510(k) clearance K163693 for IntraClude Intra-Aortic Occlusion Device, Substantially Equivalent on 2017-01-26. Applicant: Edwards Lifesciences, LLC. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciences, LLC
- Product code
- Code DXC
- Device class
- Class 2
- Regulation
- 21 CFR 870.4450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
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More clearances from Edwards Lifesciences, LLC
view allAdverse events under product code DXC
product code DXC- Death
- 14
- Injury
- 442
- Malfunction
- 2,209
- Other
- 1
- Total
- 2,666
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 K163693
K-number listed on FDA's recall record- Z-1705-2019 — IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascending aorta when the balloon is inflated.
- Z-1100-2019 — Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation. The balloon expands to occlude a range of aorta sizes from 20 to 40 mm. The large central lumen of the IntraClude Device serves three functions: accommodating the guidewire, delivering cardioplegia solution to the aortic root, and venting fluid and air from the aortic root. The two remaining lumens serve as conduits for balloon inflation/deflation and aortic root pressure monitoring.
- Z-1929-2018 — Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163693.
Data sourced from openFDA. This site is unofficial and independent of the FDA.