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FDA 510(k)

Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter

K-Number: K180302 · 2018-10-24

ApplicantCook Incorporated
Decision Date2018-10-24
Product CodeMQF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-10-24 under approval number K180302. 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 Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter?

Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter is a medical device that received FDA 510(k) clearance on 2018-10-24. It is manufactured by Cook Incorporated. The 510(k) number is K180302.

When was Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter approved by the FDA?

Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter received FDA 510(k) clearance on 2018-10-24, under approval number K180302.

What company makes Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter?

Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter is manufactured by Cook Incorporated.

What is the FDA product code for Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter?

The FDA product code for Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter is MQF.

Related Clinical Trials

NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT07610681 Midline Catheter Study ACTIVE_NOT_RECRUITING NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED NCT07585188 Neonatal Catheter Lock for Infection Prevention NOT_YET_RECRUITING NCT06411054 The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVA RECRUITING NCT07567456 Pulsatile Flushing Technique in Reducing Blockage of T-CVAD for Haemodialysis Patients RECRUITING

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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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