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FDA 510(k)

OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System

K-Number: K152361 · 2016-01-14

ApplicantLiebel-Flarsheim Company, LLC
Decision Date2016-01-14
Product CodeIZQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System is a medical device manufactured by Liebel-Flarsheim Company, LLC. It received FDA 510(k) clearance on 2016-01-14 under approval number K152361. The device is classified under product code IZQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System?

OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System is a medical device that received FDA 510(k) clearance on 2016-01-14. It is manufactured by Liebel-Flarsheim Company, LLC. The 510(k) number is K152361.

When was OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System approved by the FDA?

OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System received FDA 510(k) clearance on 2016-01-14, under approval number K152361.

What company makes OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System?

OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System is manufactured by Liebel-Flarsheim Company, LLC.

What is the FDA product code for OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System?

The FDA product code for OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System is IZQ.

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Related PubMed Literature

PMID: 40745864 A Hybrid Design Incorporating External Data to Evaluate Dexamethasone Intracameral Drug Delivery Suspension for Post-Cataract Surgery Inflammation. Clinical pharmacology and therapeutics (2025)

Other Devices by Liebel-Flarsheim Company, LLC

K193010Liebel-Flarsheim IBP Transfer Set

Related Devices (Code: IZQ)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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