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FDA 510(k)

ILT TORQUER, MODEL 114TR1

K-Number: K021243 · 2002-07-11

ApplicantIntra Luminal Therapeutics, Inc.
Decision Date2002-07-11
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ILT TORQUER, MODEL 114TR1 is the device name listed in this FDA 510(k) record. The listed applicant is Intra Luminal Therapeutics, Inc.. It received FDA 510(k) clearance on 2002-07-11 under 510(k) number K021243. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ILT TORQUER, MODEL 114TR1?

ILT TORQUER, MODEL 114TR1 is a medical device that received FDA 510(k) clearance on 2002-07-11. The listed applicant is Intra Luminal Therapeutics, Inc.. The 510(k) number is K021243.

When did ILT TORQUER, MODEL 114TR1 receive FDA 510(k) clearance?

ILT TORQUER, MODEL 114TR1 received FDA 510(k) clearance on 2002-07-11, under 510(k) number K021243.

Who is the listed applicant for ILT TORQUER, MODEL 114TR1?

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

What is the FDA product code for ILT TORQUER, MODEL 114TR1?

The FDA product code for ILT TORQUER, MODEL 114TR1 is DQX.

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Related Devices (Code: DQX)

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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.

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