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FDA 510(k)

INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE

K-Number: K990854 · 1999-08-02

Decision Date1999-08-02
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Innerdyne, Inc.. It received FDA 510(k) clearance on 1999-08-02 under 510(k) number K990854. 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 INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE?

INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE is a medical device that received FDA 510(k) clearance on 1999-08-02. The listed applicant is Innerdyne, Inc.. The 510(k) number is K990854.

When did INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE receive FDA 510(k) clearance?

INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE received FDA 510(k) clearance on 1999-08-02, under 510(k) number K990854.

Who is the listed applicant for INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE?

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

What is the FDA product code for INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE?

The FDA product code for INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE 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 Innerdyne, 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 12 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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