FDA 510(k)

Kitazato IUI 管套

K号: K162667 · 2017-05-11

决定日期2017-05-11

产品代码MQF

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决定实质等同

器械摘要

Kitazato IUI Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2017-05-11 under 510(k) number K162667. The device is classified under product code MQF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Kitazato IUI Catheter?

Kitazato IUI Catheter is a medical device that received FDA 510(k) clearance on 2017-05-11. The listed applicant is Kitazato Corporation. The 510(k) number is K162667.

When did Kitazato IUI Catheter receive FDA 510(k) clearance?

Kitazato IUI Catheter received FDA 510(k) clearance on 2017-05-11, under 510(k) number K162667.

Who is the listed applicant for Kitazato IUI Catheter?

The FDA 510(k) record lists Kitazato Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kitazato IUI Catheter?

The FDA product code for Kitazato IUI Catheter is MQF.

列明Kitazato Corporation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。

K260248超快速升温 K251305超快速玻璃化；超快速温控 K200249顺序培养基（受精培养基[无HSA/rHA，含HSA，含rHA]，分裂培养基[无HSA/rHA，含HSA，含rHA]，囊胚培养基[无HSA/rHA，含HSA，含rHA]）K193522iMedium 单步；iMedium 单步带HSA；iMedium 单步带rHA K192845精子冷冻，精子冰箱 K192540Kitazato ET 管套

查看所有 13 个设备 →

相关器械（代码：MQF）

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。

K253354Minvitro 胚胎移植导管 (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)Guangzhou Hehong Biotech Co., Ltd.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)Vitrolife Sweden AB K240307VitaVitro 胚胎移植导管（型号 ET-S、ET-SI、ET-A、ET-I、ET-IH）Shenzhen Vitavitro Biotech Co., Ltd.K231730FemaSeed 宫腔内人工授精Femasys, Inc.K220010百合单次使用无菌胚胎移植导管Shanghai Horizon Medical Technology Co., Ltd.K200248Allwin胚胎移植导管（ETC），Allwin ETC型芯和软塞Allwin Medical Devices, Inc.

官方来源

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