K254149

Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)

510(k) 号: K254149
器械名称: Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)
申请人: Sterilmed, Inc. MN · US
产品代码: OWQ — Reprocessed Intravascular Ultrasound Catheter
批准日期: 2026-06-29
受理日期: 2025-12-22
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Cardiovascular

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也可从 FDA 官方下载： K254149.pdf

FDA 官方记录： K254149

数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。