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FDA 510(k)

Miethke Shunt System GAV 2.0 and SA 2.0 Valves

K-Number: K190174 · 2019-07-05

ApplicantAesculap, Inc.
Decision Date2019-07-05
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Miethke Shunt System GAV 2.0 and SA 2.0 Valves is a medical device manufactured by Aesculap, Inc.. It received FDA 510(k) clearance on 2019-07-05 under approval number K190174. 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 Miethke Shunt System GAV 2.0 and SA 2.0 Valves?

Miethke Shunt System GAV 2.0 and SA 2.0 Valves is a medical device that received FDA 510(k) clearance on 2019-07-05. It is manufactured by Aesculap, Inc.. The 510(k) number is K190174.

When was Miethke Shunt System GAV 2.0 and SA 2.0 Valves approved by the FDA?

Miethke Shunt System GAV 2.0 and SA 2.0 Valves received FDA 510(k) clearance on 2019-07-05, under approval number K190174.

What company makes Miethke Shunt System GAV 2.0 and SA 2.0 Valves?

Miethke Shunt System GAV 2.0 and SA 2.0 Valves is manufactured by Aesculap, Inc..

What is the FDA product code for Miethke Shunt System GAV 2.0 and SA 2.0 Valves?

The FDA product code for Miethke Shunt System GAV 2.0 and SA 2.0 Valves is JXG.

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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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