FDA 510(k)

TRAC-WRIGHT SYSTEM, MODEL TW2

K-Number: K910594 · 1991-09-23

Decision Date1991-09-23

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TRAC-WRIGHT SYSTEM, MODEL TW2 is the device name listed in this FDA 510(k) record. The listed applicant is Dow Corning Wright. It received FDA 510(k) clearance on 1991-09-23 under 510(k) number K910594. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAC-WRIGHT SYSTEM, MODEL TW2?

TRAC-WRIGHT SYSTEM, MODEL TW2 is a medical device that received FDA 510(k) clearance on 1991-09-23. The listed applicant is Dow Corning Wright. The 510(k) number is K910594.

When did TRAC-WRIGHT SYSTEM, MODEL TW2 receive FDA 510(k) clearance?

TRAC-WRIGHT SYSTEM, MODEL TW2 received FDA 510(k) clearance on 1991-09-23, under 510(k) number K910594.

Who is the listed applicant for TRAC-WRIGHT SYSTEM, MODEL TW2?

The FDA 510(k) record lists Dow Corning Wright as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRAC-WRIGHT SYSTEM, MODEL TW2?

The FDA product code for TRAC-WRIGHT SYSTEM, MODEL TW2 is DXT.

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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.