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FDA 510(k)

EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS

K-Number: K972994 · 1997-11-03

ApplicantIntegra Neurocare, LLC
Decision Date1997-11-03
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Integra Neurocare, LLC. It received FDA 510(k) clearance on 1997-11-03 under 510(k) number K972994. 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 CSF DRAINAGE MANAGEMENT SYSTEMS?

EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS is a medical device that received FDA 510(k) clearance on 1997-11-03. The listed applicant is Integra Neurocare, LLC. The 510(k) number is K972994.

When did EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS receive FDA 510(k) clearance?

EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS received FDA 510(k) clearance on 1997-11-03, under 510(k) number K972994.

Who is the listed applicant for EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS?

The FDA 510(k) record lists Integra Neurocare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS?

The FDA product code for EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS is JXG.

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Other records listing Integra Neurocare, LLC 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.

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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.

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