Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe— 510(k) K193379
Substantially EquivalentEdwards Lifesciences, LLC
FDA 510(k) clearance K193379 for Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe, Substantially Equivalent on 2020-06-12. Applicant: Edwards Lifesciences, LLC. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciences, LLC
- Product code
- Code DXE
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code DXE
view allMore clearances from Edwards Lifesciences, LLC
view allAdverse events under product code DXE
product code DXE- Death
- 27
- Injury
- 258
- Malfunction
- 2,266
- Total
- 2,551
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 K193379
K-number listed on FDA's recall record- Z-0146-2023 — Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP
- Z-0147-2023 — Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193379.
Data sourced from openFDA. This site is unofficial and independent of the FDA.