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FDA 510(k)

INTRASTENT II

K-Number: K990592 · 1999-09-01

Decision Date1999-09-01
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

INTRASTENT II is the device name listed in this FDA 510(k) record. The listed applicant is Intratherapeutics, Inc.. It received FDA 510(k) clearance on 1999-09-01 under 510(k) number K990592. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the INTRASTENT II?

INTRASTENT II is a medical device that received FDA 510(k) clearance on 1999-09-01. The listed applicant is Intratherapeutics, Inc.. The 510(k) number is K990592.

When did INTRASTENT II receive FDA 510(k) clearance?

INTRASTENT II received FDA 510(k) clearance on 1999-09-01, under 510(k) number K990592.

Who is the listed applicant for INTRASTENT II?

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

What is the FDA product code for INTRASTENT II?

The FDA product code for INTRASTENT II 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 Intratherapeutics, 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.

View all 15 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

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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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