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FDA 510(k)

HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS.

K-Number: K895524 · 1990-04-10

ApplicantTheramed, Inc.
Decision Date1990-04-10
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS. is the device name listed in this FDA 510(k) record. The listed applicant is Theramed, Inc.. It received FDA 510(k) clearance on 1990-04-10 under 510(k) number K895524. 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 HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS.?

HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS. is a medical device that received FDA 510(k) clearance on 1990-04-10. The listed applicant is Theramed, Inc.. The 510(k) number is K895524.

When did HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS. receive FDA 510(k) clearance?

HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS. received FDA 510(k) clearance on 1990-04-10, under 510(k) number K895524.

Who is the listed applicant for HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS.?

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

What is the FDA product code for HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS.?

The FDA product code for HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS. is JXG.

Related Clinical Trials

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Other records listing Theramed, Inc. 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.

K910004FURUI SHUNT, 2-WAY AND 3-WAY

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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.

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