FDA 510(k)

VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)

K-Number: K240307 · 2024-08-16

ApplicantShenzhen Vitavitro Biotech Co., Ltd.

Decision Date2024-08-16

Product CodeMQF

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) is a medical device manufactured by Shenzhen Vitavitro Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-08-16 under approval number K240307. The device is classified under product code MQF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)?

VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) is a medical device that received FDA 510(k) clearance on 2024-08-16. It is manufactured by Shenzhen Vitavitro Biotech Co., Ltd.. The 510(k) number is K240307.

When was VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) approved by the FDA?

VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) received FDA 510(k) clearance on 2024-08-16, under approval number K240307.

What company makes VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)?

VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) is manufactured by Shenzhen Vitavitro Biotech Co., Ltd..

What is the FDA product code for VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)?

The FDA product code for VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) is MQF.

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Other Devices by Shenzhen Vitavitro Biotech Co., Ltd.

K1910631-Step Culture Medium K200408VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium K212410VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium K240523VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)

Related Devices (Code: MQF)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.