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FDA 510(k)

CodMan Certas Plus Programmable Valve

K-Number: K182265 · 2018-11-20

ApplicantIntegra Lifesciences Corp.
Decision Date2018-11-20
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CodMan Certas Plus Programmable Valve is a medical device manufactured by Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2018-11-20 under approval number K182265. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CodMan Certas Plus Programmable Valve?

CodMan Certas Plus Programmable Valve is a medical device that received FDA 510(k) clearance on 2018-11-20. It is manufactured by Integra Lifesciences Corp.. The 510(k) number is K182265.

When was CodMan Certas Plus Programmable Valve approved by the FDA?

CodMan Certas Plus Programmable Valve received FDA 510(k) clearance on 2018-11-20, under approval number K182265.

What company makes CodMan Certas Plus Programmable Valve?

CodMan Certas Plus Programmable Valve is manufactured by Integra Lifesciences Corp..

What is the FDA product code for CodMan Certas Plus Programmable Valve?

The FDA product code for CodMan Certas Plus Programmable Valve is JXG.

Other Devices by Integra Lifesciences Corp.

K181902Codman Certas Plus Electronic Tool Kit K183581Codman Disposable Perforators K183406CereLink ICP Monitor, CereLink ICP Extension Cable PMA P840062MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID PMA P900033Dressing, wound and burn, interactive

Related Devices (Code: JXG)

K162437Codman EDS3 CSF External Drainage SystemCodman & Shurtleff, Inc. K161605Smart External Drain (SED) SystemAqueduct Critical Care, Inc. K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsIntegra LifeSciences Corporation K152700StrataMR Valves and ShuntsMedtronic Neurosurgery K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingIntegra LifeSciences Corporation K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating AccessoryIntegra LifeSciences Corporation

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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