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FDA 510(k)

INTHERM RADIALLY EXPANDING DILATER

K-Number: K912971 · 1991-09-13

Decision Date1991-09-13
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTHERM RADIALLY EXPANDING DILATER 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 1991-09-13 under 510(k) number K912971. 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 RADIALLY EXPANDING DILATER?

INTHERM RADIALLY EXPANDING DILATER is a medical device that received FDA 510(k) clearance on 1991-09-13. The listed applicant is Interventional Therapeutics Corp.. The 510(k) number is K912971.

When did INTHERM RADIALLY EXPANDING DILATER receive FDA 510(k) clearance?

INTHERM RADIALLY EXPANDING DILATER received FDA 510(k) clearance on 1991-09-13, under 510(k) number K912971.

Who is the listed applicant for INTHERM RADIALLY EXPANDING DILATER?

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 RADIALLY EXPANDING DILATER?

The FDA product code for INTHERM RADIALLY EXPANDING DILATER 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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