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FDA 510(k)

ILT ADVANCING MECHANISM, MODEL A115AMI

K-Number: K021638 · 2002-07-26

ApplicantIntra Luminal Therapeutics, Inc.
Decision Date2002-07-26
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ILT ADVANCING MECHANISM, MODEL A115AMI 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 2002-07-26 under 510(k) number K021638. 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 ADVANCING MECHANISM, MODEL A115AMI?

ILT ADVANCING MECHANISM, MODEL A115AMI is a medical device that received FDA 510(k) clearance on 2002-07-26. The listed applicant is Intra Luminal Therapeutics, Inc.. The 510(k) number is K021638.

When did ILT ADVANCING MECHANISM, MODEL A115AMI receive FDA 510(k) clearance?

ILT ADVANCING MECHANISM, MODEL A115AMI received FDA 510(k) clearance on 2002-07-26, under 510(k) number K021638.

Who is the listed applicant for ILT ADVANCING MECHANISM, MODEL A115AMI?

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 ADVANCING MECHANISM, MODEL A115AMI?

The FDA product code for ILT ADVANCING MECHANISM, MODEL A115AMI 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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