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FDA 510(k)

Pivet and Soft-Pass Embryo Transfer Catheter Sets

K-Number: K173103 · 2018-04-13

ApplicantCook Incorporated
Decision Date2018-04-13
Product CodeMQF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Pivet and Soft-Pass Embryo Transfer Catheter Sets is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-04-13 under approval number K173103. 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 Pivet and Soft-Pass Embryo Transfer Catheter Sets?

Pivet and Soft-Pass Embryo Transfer Catheter Sets is a medical device that received FDA 510(k) clearance on 2018-04-13. It is manufactured by Cook Incorporated. The 510(k) number is K173103.

When was Pivet and Soft-Pass Embryo Transfer Catheter Sets approved by the FDA?

Pivet and Soft-Pass Embryo Transfer Catheter Sets received FDA 510(k) clearance on 2018-04-13, under approval number K173103.

What company makes Pivet and Soft-Pass Embryo Transfer Catheter Sets?

Pivet and Soft-Pass Embryo Transfer Catheter Sets is manufactured by Cook Incorporated.

What is the FDA product code for Pivet and Soft-Pass Embryo Transfer Catheter Sets?

The FDA product code for Pivet and Soft-Pass Embryo Transfer Catheter Sets 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

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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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