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FDA 510(k)

EXTERNAL DRAINAGE SET

K-Number: K032817 · 2003-10-06

ApplicantIntegra Neurosciences Implants S.A.
Decision Date2003-10-06
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EXTERNAL DRAINAGE SET 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 2003-10-06 under 510(k) number K032817. 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 EXTERNAL DRAINAGE SET?

EXTERNAL DRAINAGE SET is a medical device that received FDA 510(k) clearance on 2003-10-06. The listed applicant is Integra Neurosciences Implants S.A.. The 510(k) number is K032817.

When did EXTERNAL DRAINAGE SET receive FDA 510(k) clearance?

EXTERNAL DRAINAGE SET received FDA 510(k) clearance on 2003-10-06, under 510(k) number K032817.

Who is the listed applicant for EXTERNAL DRAINAGE SET?

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 EXTERNAL DRAINAGE SET?

The FDA product code for EXTERNAL DRAINAGE SET 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 VALVEK040201MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEMK033698CONTOUR-FLEX VALVE AND SHUNT SYSTEM

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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