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FDA 510(k)

Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter

K-Number: K172051 · 2018-01-10

ApplicantCook Incorporated
Decision Date2018-01-10
Product CodeMQF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-01-10 under approval number K172051. 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 Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter?

Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter is a medical device that received FDA 510(k) clearance on 2018-01-10. It is manufactured by Cook Incorporated. The 510(k) number is K172051.

When was Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter approved by the FDA?

Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter received FDA 510(k) clearance on 2018-01-10, under approval number K172051.

What company makes Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter?

Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter is manufactured by Cook Incorporated.

What is the FDA product code for Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter?

The FDA product code for Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter is MQF.

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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 K162064CrossBay IVF Embryo Transfer Catheter SetCrossbay Medical, Inc.

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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