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FDA 510(k)

INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D.

K-Number: K934377 · 1994-02-07

Decision Date1994-02-07
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D. is the device name listed in this FDA 510(k) record. The listed applicant is Interventional Thermodynamics, Inc.. It received FDA 510(k) clearance on 1994-02-07 under 510(k) number K934377. 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 REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D.?

INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D. is a medical device that received FDA 510(k) clearance on 1994-02-07. The listed applicant is Interventional Thermodynamics, Inc.. The 510(k) number is K934377.

When did INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D. receive FDA 510(k) clearance?

INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D. received FDA 510(k) clearance on 1994-02-07, under 510(k) number K934377.

Who is the listed applicant for INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D.?

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

What is the FDA product code for INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D.?

The FDA product code for INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D. 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.

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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