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FDA 510(k)

INTHERM STASIS VALVE SYSTEM

K-Number: K931025 · 1993-09-28

Decision Date1993-09-28
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTHERM STASIS VALVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Interventional Therapeutics Corp.. It received FDA 510(k) clearance on 1993-09-28 under 510(k) number K931025. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTHERM STASIS VALVE SYSTEM?

INTHERM STASIS VALVE SYSTEM is a medical device that received FDA 510(k) clearance on 1993-09-28. The listed applicant is Interventional Therapeutics Corp.. The 510(k) number is K931025.

When did INTHERM STASIS VALVE SYSTEM receive FDA 510(k) clearance?

INTHERM STASIS VALVE SYSTEM received FDA 510(k) clearance on 1993-09-28, under 510(k) number K931025.

Who is the listed applicant for INTHERM STASIS VALVE SYSTEM?

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

What is the FDA product code for INTHERM STASIS VALVE SYSTEM?

The FDA product code for INTHERM STASIS VALVE SYSTEM is FGE.

Related Clinical Trials

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.

Other records listing Interventional Therapeutics Corp. 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.

View all 28 devices →

Related Devices (Code: FGE)

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.

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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