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FDA Import Refusal 799-7659964-8/13/1 — SHOCKWAVE MEDICAL INC

SHOCKWAVE MEDICAL INC — FEI 3015053858

The FDA refused shipment 799-7659964-8/13/1 from SHOCKWAVE MEDICAL INC (United States) on May 21, 2025. The refused product falls under Devices — SHOCKWAVE INTRAVASCULAR LITHOTRIPSY SYSTEM. Cited charge: 3280

Refusal Details

Date
May 21, 2025
Country
United States
Product Category
Devices
Product Code
74QMG SHOCKWAVE INTRAVASCULAR LITHOTRIPSY SYSTEM
Charges
3280

Recent inspections

  • 1108199 (NAI Wed Oct 09 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1095174 (NAI Fri Jun 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources