Home / Import refusals / AEK-4699714-2/11/1

FDA Import Refusal AEK-4699714-2/11/1 — Maquet Cardiovascular, LLC

Maquet Cardiovascular, LLC — FEI 2242352

The FDA refused shipment AEK-4699714-2/11/1 from Maquet Cardiovascular, LLC (United States) on February 16, 2024. The refused product falls under Devices — DEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES. Cited charge: 3280

Refusal Details

Date
February 16, 2024
Country
United States
Product Category
Devices
Product Code
79GEI DEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Charges
3280

Recent inspections

  • 1230807 (OAI Thu Jul 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1136869 (VAI Fri Feb 26 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 994785 (OAI Thu Sep 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 851685 (OAI Wed Oct 16 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 778533 (OAI Thu Jun 14 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

FDA data resources