Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CONTOUR-FLEX VALVE AND SHUNT SYSTEM

K-Number: K033698 · 2003-12-17

ApplicantIntegra Neurosciences Implants S.A.
Decision Date2003-12-17
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CONTOUR-FLEX VALVE AND SHUNT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Integra Neurosciences Implants S.A.. It received FDA 510(k) clearance on 2003-12-17 under 510(k) number K033698. 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 CONTOUR-FLEX VALVE AND SHUNT SYSTEM?

CONTOUR-FLEX VALVE AND SHUNT SYSTEM is a medical device that received FDA 510(k) clearance on 2003-12-17. The listed applicant is Integra Neurosciences Implants S.A.. The 510(k) number is K033698.

When did CONTOUR-FLEX VALVE AND SHUNT SYSTEM receive FDA 510(k) clearance?

CONTOUR-FLEX VALVE AND SHUNT SYSTEM received FDA 510(k) clearance on 2003-12-17, under 510(k) number K033698.

Who is the listed applicant for CONTOUR-FLEX VALVE AND SHUNT SYSTEM?

The FDA 510(k) record lists Integra Neurosciences Implants S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTOUR-FLEX VALVE AND SHUNT SYSTEM?

The FDA product code for CONTOUR-FLEX VALVE AND SHUNT SYSTEM is JXG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Integra Neurosciences Implants S.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K081773OSV IIK042558EQUI-FLOW VALVE AND SHUNT SYSTEMK042192LOW FLOW OSV II HYDROCEPHALUS VALVEK040201MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEMK032817EXTERNAL DRAINAGE SET

Related Devices (Code: JXG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)Integra Lifesciences Production CorporationK251598IntellidropBrainspace, Inc.K250636Sophy Mini Monopressure Valve (SM1)SophysaK252514EVAC-MRIPhasor Health, LLCK243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production CorporationK243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)Integra Lifesciences Production 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.

↑