UltraCor Twirl 乳腺组织标记器
K号: K152510 · 2016-05-13
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决定日期2016-05-13
产品代码NEU
咨询委员会SU
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决定实质等同
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 2016-05-13 under 510(k) number K152510. 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 2016-05-13. The listed applicant is Bard Peripheral Vascular, Inc.. The 510(k) number is K152510.
When did UltraCor Twirl Breast Tissue Marker receive FDA 510(k) clearance?
UltraCor Twirl Breast Tissue Marker received FDA 510(k) clearance on 2016-05-13, under 510(k) number K152510.
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。
K253761HydroMARK™ Plus 乳腺活检位点标记（蜻蜓形状）；HydroMARK™ Plus 乳腺活检位点标记（蜂鸟形状）Devicor Medical Products, Inc.K253888MOLLI 2 系统Stryker EndoscopyK252892SCOUT MD 外科引导系统Merit Medical Systems, Inc.K251989VizMark 预装组织标记器设备（VM-0001）Breast-Med, Inc.K251748MammoSTAR活检位点标识器Carbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ 乳腺组织标记器Bard Peripheral Vascular, Inc.
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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