FDA Import Refusal 1FX-5141256-6/10002/1 — SWAV CR SRL
The FDA refused shipment 1FX-5141256-6/10002/1 from SWAV CR SRL (Costa Rica) on May 18, 2026. The refused product falls under Devices — ABLATION SYSTEM, HIGH INTENSITY FOCUS ULTRASOUND (HIFU), SOFT TISSUE. Cited charges: 118,3280,341,508
Refusal Details
- Date
- May 18, 2026
- Country
- Costa Rica
- Product Category
- Devices
- Product Code
- 79PZC ABLATION SYSTEM, HIGH INTENSITY FOCUS ULTRASOUND (HIFU), SOFT TISSUE
- Charges
- 118,3280,341,508