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FDA 510(k)

CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)

K-Number: K172022 · 2017-10-03

ApplicantCodman & Shurtleff, Inc.
Decision Date2017-10-03
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) is a medical device manufactured by Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2017-10-03 under approval number K172022. 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 Hydrocephalus Valves, Catheters & Accessories (Bundled)?

CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) is a medical device that received FDA 510(k) clearance on 2017-10-03. It is manufactured by Codman & Shurtleff, Inc.. The 510(k) number is K172022.

When was CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) approved by the FDA?

CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) received FDA 510(k) clearance on 2017-10-03, under approval number K172022.

What company makes CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)?

CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) is manufactured by Codman & Shurtleff, Inc..

What is the FDA product code for CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)?

The FDA product code for CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) is JXG.

Related PubMed Literature

PMID: 41517921 Approval Lag for Ablation Catheters: A Comparative Analysis of Regulatory Timelines in the European Union, United States, and Japan. Journal of cardiovascular electrophysiology (2026)

Other Devices by Codman & Shurtleff, Inc.

K162437Codman EDS3 CSF External Drainage System K153347Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit K172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag K171862GALAXY G3 Mini Microcoil Delivery System K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System

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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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