UltraCor™ Twirl™ 乳腺组织标记器
K号: K243642 · 2025-03-24
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决定日期2025-03-24
产品代码NEU
咨询委员会SU
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器械摘要
UltraCor™ Twirl™ Breast Tissue Marker is the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2025-03-24 under 510(k) number K243642. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the UltraCor™ Twirl™ Breast Tissue Marker?
UltraCor™ Twirl™ Breast Tissue Marker is a medical device that received FDA 510(k) clearance on 2025-03-24. The listed applicant is Bard Peripheral Vascular, Inc.. The 510(k) number is K243642.
When did UltraCor™ Twirl™ Breast Tissue Marker receive FDA 510(k) clearance?
UltraCor™ Twirl™ Breast Tissue Marker received FDA 510(k) clearance on 2025-03-24, under 510(k) number K243642.
Who is the listed applicant for UltraCor™ Twirl™ Breast Tissue Marker?
FDA 510(k)记录将Bard Peripheral Vascular, Inc.列为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for UltraCor™ Twirl™ Breast Tissue Marker?
The FDA product code for UltraCor™ Twirl™ Breast Tissue Marker is NEU.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Bard Peripheral Vascular, Inc.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：NEU）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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