FDA 510(k)

POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400

K-Number: K042481 · 2004-12-14

Decision Date2004-12-14

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 is the device name listed in this FDA 510(k) record. The listed applicant is Sophysa SA. It received FDA 510(k) clearance on 2004-12-14 under 510(k) number K042481. 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, MODELS SPV-140, SPV-300, SPV-400?

POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 is a medical device that received FDA 510(k) clearance on 2004-12-14. The listed applicant is Sophysa SA. The 510(k) number is K042481.

When did POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 receive FDA 510(k) clearance?

POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 received FDA 510(k) clearance on 2004-12-14, under 510(k) number K042481.

Who is the listed applicant for POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400?

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, MODELS SPV-140, SPV-300, SPV-400?

The FDA product code for POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 is JXG.

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Other records listing Sophysa SA as applicant

K162108Pressio 2 ICP Monitoring System K091328SIPHONX GRAVITATIONAL ANTISIPHON DEVICE K090342POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400 K062584PRESSIO ICP MONITORING SYSTEM K031097POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB K013488SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8

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Related Devices (Code: JXG)

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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.