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FDA 510(k)

MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM

K-Number: K040201 · 2004-02-26

ApplicantIntegra Neurosciences Implants S.A.
Decision Date2004-02-26
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO BURR HOLE 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 2004-02-26 under 510(k) number K040201. 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 MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM?

MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-02-26. The listed applicant is Integra Neurosciences Implants S.A.. The 510(k) number is K040201.

When did MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM received FDA 510(k) clearance on 2004-02-26, under 510(k) number K040201.

Who is the listed applicant for MODIFICATION TO BURR HOLE 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 MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM?

The FDA product code for MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM is JXG.

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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 VALVEK033698CONTOUR-FLEX 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

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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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