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FDA 510(k)

FURUI SHUNT, 2-WAY AND 3-WAY

K-Number: K910004 · 1991-09-19

ApplicantTheramed, Inc.
Decision Date1991-09-19
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FURUI SHUNT, 2-WAY AND 3-WAY is the device name listed in this FDA 510(k) record. The listed applicant is Theramed, Inc.. It received FDA 510(k) clearance on 1991-09-19 under 510(k) number K910004. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FURUI SHUNT, 2-WAY AND 3-WAY?

FURUI SHUNT, 2-WAY AND 3-WAY is a medical device that received FDA 510(k) clearance on 1991-09-19. The listed applicant is Theramed, Inc.. The 510(k) number is K910004.

When did FURUI SHUNT, 2-WAY AND 3-WAY receive FDA 510(k) clearance?

FURUI SHUNT, 2-WAY AND 3-WAY received FDA 510(k) clearance on 1991-09-19, under 510(k) number K910004.

Who is the listed applicant for FURUI SHUNT, 2-WAY AND 3-WAY?

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 FURUI SHUNT, 2-WAY AND 3-WAY?

The FDA product code for FURUI SHUNT, 2-WAY AND 3-WAY is DWF.

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.

K895524HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS.

Related Devices (Code: DWF)

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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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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