卵泡抽吸套装，减少单腔
K号: K172050 · 2017-11-21
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决定日期2017-11-21
产品代码MQE
咨询委员会OB
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决定实质等同
器械摘要
Follicle Aspiration Set, Reduced Single Lumen is the device name listed in this FDA 510(k) record. The listed applicant is Vitrolife Sweden AB. It received FDA 510(k) clearance on 2017-11-21 under 510(k) number K172050. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Follicle Aspiration Set, Reduced Single Lumen?
Follicle Aspiration Set, Reduced Single Lumen is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Vitrolife Sweden AB. The 510(k) number is K172050.
When did Follicle Aspiration Set, Reduced Single Lumen receive FDA 510(k) clearance?
Follicle Aspiration Set, Reduced Single Lumen received FDA 510(k) clearance on 2017-11-21, under 510(k) number K172050.
Who is the listed applicant for Follicle Aspiration Set, Reduced Single Lumen?
The FDA 510(k) record lists Vitrolife Sweden AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Follicle Aspiration Set, Reduced Single Lumen?
The FDA product code for Follicle Aspiration Set, Reduced Single Lumen is MQE.
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Vitrolife Sweden AB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。
K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)K241662超声探头罩K240605Ultra RapidWarm™ BlastK202862Gx-IVF, Gx-TL, Gx-MOPS PLUSK183486RapidVit® 卵母细胞，RapidWarm® 卵母细胞K181461Rapid-i®试剂盒
相关器械（代码：MQE）
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。
K253121Giftlife单腔卵母细胞采集针，Giftlife双腔卵母细胞采集针Gimbo Medical Technology Shenzhen Co., Ltd.K240523VitaVitro® 单腔卵母细胞采集针（ORNS-17G，ORNS-18G），VitaVitro® 双腔卵母细胞采集针（ORND-17G）Shenzhen Vitavitro Biotech Co., Ltd.K232163Lotus单腔卵泡吸管针；Lotus双腔卵泡吸管针Zhejiang Horizon Medical Technology Co., Ltd.K190590Allwin卵母细胞采集针（ACE单腔卵母细胞采集针，OVUMPICK双腔卵母细胞采集针，ACE-FL单腔卵母细胞采集针带冲洗线，ACE-M手动单腔卵母细胞采集针）Allwin Medical Devices, Inc.K191291华莱士双腔卵母细胞采集系统CooperSurgical, Inc.K182959华莱士双腔卵母细胞采集系统CooperSurgical, 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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