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FDA 510(k)

Mikro-Cath Pressure Catheter

K-Number: K163376 · 2017-03-10

ApplicantMillar, Inc.
Decision Date2017-03-10
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Mikro-Cath Pressure Catheter is a medical device manufactured by Millar, Inc.. It received FDA 510(k) clearance on 2017-03-10 under approval number K163376. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mikro-Cath Pressure Catheter?

Mikro-Cath Pressure Catheter is a medical device that received FDA 510(k) clearance on 2017-03-10. It is manufactured by Millar, Inc.. The 510(k) number is K163376.

When was Mikro-Cath Pressure Catheter approved by the FDA?

Mikro-Cath Pressure Catheter received FDA 510(k) clearance on 2017-03-10, under approval number K163376.

What company makes Mikro-Cath Pressure Catheter?

Mikro-Cath Pressure Catheter is manufactured by Millar, Inc..

What is the FDA product code for Mikro-Cath Pressure Catheter?

The FDA product code for Mikro-Cath Pressure Catheter is DXO.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT05372679 REDUCED 1 - Renal Denervation Using Ultrasonic Catheter EmitteD Energy Study / ACTIVE_NOT_RECRUITING NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT07179705 Using a Hypotension Prediction Index to Prevent Low Blood Pressure During Dialysis in ICU Patients RECRUITING NCT06297291 Global Paradise System US Post Approval Study RECRUITING NCT05970549 Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage RECRUITING

Related Devices (Code: DXO)

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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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