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FDA 510(k)

POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB

K-Number: K031097 · 2004-02-26

ApplicantSophysa SA
Decision Date2004-02-26
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB is the device name listed in this FDA 510(k) record. The listed applicant is Sophysa SA. It received FDA 510(k) clearance on 2004-02-26 under 510(k) number K031097. 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 POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB?

POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB is a medical device that received FDA 510(k) clearance on 2004-02-26. The listed applicant is Sophysa SA. The 510(k) number is K031097.

When did POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB receive FDA 510(k) clearance?

POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB received FDA 510(k) clearance on 2004-02-26, under 510(k) number K031097.

Who is the listed applicant for POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB?

The FDA 510(k) record lists Sophysa SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB?

The FDA product code for POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB is JXG.

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Other records listing Sophysa SA 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.

K162108Pressio 2 ICP Monitoring SystemK091328SIPHONX GRAVITATIONAL ANTISIPHON DEVICEK090342POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400K062584PRESSIO ICP MONITORING SYSTEMK042481POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400K013488SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8

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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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