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FDA 510(k)

CrossBay IVF Embryo Transfer Catheter Set

K-Number: K162064 · 2017-01-05

ApplicantCrossbay Medical, Inc.
Decision Date2017-01-05
Product CodeMQF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CrossBay IVF Embryo Transfer Catheter Set is a medical device manufactured by Crossbay Medical, Inc.. It received FDA 510(k) clearance on 2017-01-05 under approval number K162064. 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 CrossBay IVF Embryo Transfer Catheter Set?

CrossBay IVF Embryo Transfer Catheter Set is a medical device that received FDA 510(k) clearance on 2017-01-05. It is manufactured by Crossbay Medical, Inc.. The 510(k) number is K162064.

When was CrossBay IVF Embryo Transfer Catheter Set approved by the FDA?

CrossBay IVF Embryo Transfer Catheter Set received FDA 510(k) clearance on 2017-01-05, under approval number K162064.

What company makes CrossBay IVF Embryo Transfer Catheter Set?

CrossBay IVF Embryo Transfer Catheter Set is manufactured by Crossbay Medical, Inc..

What is the FDA product code for CrossBay IVF Embryo Transfer Catheter Set?

The FDA product code for CrossBay IVF Embryo Transfer Catheter Set is MQF.

Related Clinical Trials

NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING NCT07396181 Standardization of Variable Conditions of Embryo Transfer Into the Uterine Cavity in the Procedure of Medically Assisted Procreation in Humans RECRUITING

Related Devices (Code: MQF)

K172321Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination CathetersCook Incorporated K163318Soules Intrauterine Insemination CatheterCook Incorporated K162878Kitazato ET CathetersKitazato Corporation K162667Kitazato IUI CatheterKitazato Corporation K161547Transem and EchoGen Embryo Transfer CathetersOrigio A/S K180302Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing CatheterCook Incorporated

Official Source

View on FDA Database →

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

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