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FDA 510(k)

ILT DEFLECTING CATHETER, MODEL C114ND1

K-Number: K010531 · 2001-04-18

ApplicantIntra Luminal Therapeutics, Inc.
Decision Date2001-04-18
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ILT DEFLECTING CATHETER, MODEL C114ND1 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 2001-04-18 under 510(k) number K010531. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ILT DEFLECTING CATHETER, MODEL C114ND1?

ILT DEFLECTING CATHETER, MODEL C114ND1 is a medical device that received FDA 510(k) clearance on 2001-04-18. The listed applicant is Intra Luminal Therapeutics, Inc.. The 510(k) number is K010531.

When did ILT DEFLECTING CATHETER, MODEL C114ND1 receive FDA 510(k) clearance?

ILT DEFLECTING CATHETER, MODEL C114ND1 received FDA 510(k) clearance on 2001-04-18, under 510(k) number K010531.

Who is the listed applicant for ILT DEFLECTING CATHETER, MODEL C114ND1?

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 DEFLECTING CATHETER, MODEL C114ND1?

The FDA product code for ILT DEFLECTING CATHETER, MODEL C114ND1 is DQY.

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Other records listing Intra Luminal Therapeutics, 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.

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Related Devices (Code: DQY)

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.

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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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