Home / Import refusals / 310-5195213-8/2/1

FDA Import Refusal 310-5195213-8/2/1 — Edwards Lifesciences, LLC

Edwards Lifesciences, LLC — FEI 2015691

The FDA refused shipment 310-5195213-8/2/1 from Edwards Lifesciences, LLC (United States) on November 18, 2002. The refused product falls under Devices — CATHETER, EMBOLECTOMY. Cited charge: 118 This firm has 5 or more other import refusals on record.

Refusal Details

Date
November 18, 2002
Country
United States
Product Category
Devices
Product Code
74DXE CATHETER, EMBOLECTOMY
Charges
118

Recent inspections

  • 1229680 (NAI Thu Aug 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1194166 (NAI Tue Dec 06 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100450 (NAI Mon Aug 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1093187 (VAI Fri Jun 14 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 959741 (NAI Fri Feb 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 101-8366633-8/231/1 (Thu Oct 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 101-8218276-6/71/1 (Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 101-8218276-6/121/1 (Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 101-8218276-6/181/1 (Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 101-8218276-6/61/1 (Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources