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FDA 510(k)

Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter

K-Number: K173686 · 2018-04-11

ApplicantCook Incorporated
Decision Date2018-04-11
Product CodeMQF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-04-11 under approval number K173686. 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 Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter?

Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter is a medical device that received FDA 510(k) clearance on 2018-04-11. It is manufactured by Cook Incorporated. The 510(k) number is K173686.

When was Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter approved by the FDA?

Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter received FDA 510(k) clearance on 2018-04-11, under approval number K173686.

What company makes Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter?

Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter is manufactured by Cook Incorporated.

What is the FDA product code for Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter?

The FDA product code for Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter is MQF.

Related Clinical Trials

NCT07610681 Midline Catheter Study ACTIVE_NOT_RECRUITING NCT07585188 Neonatal Catheter Lock for Infection Prevention NOT_YET_RECRUITING NCT07512986 Simulation and Video Training for Phlebitis Recognition and Clinical Decision-Making in Nursing Students NOT_YET_RECRUITING NCT04498598 Structural Modification In Supraglottic Airway Device RECRUITING NCT02633124 Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants. TERMINATED NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING

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Related Devices (Code: MQF)

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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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