FDA 510(k)

MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM

K-Number: K041973 · 2004-08-16

ApplicantIntra Luminal Therapeutics, Inc.

Decision Date2004-08-16

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM 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 2004-08-16 under 510(k) number K041973. 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 MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM?

MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM is a medical device that received FDA 510(k) clearance on 2004-08-16. The listed applicant is Intra Luminal Therapeutics, Inc.. The 510(k) number is K041973.

When did MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM received FDA 510(k) clearance on 2004-08-16, under 510(k) number K041973.

Who is the listed applicant for MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM?

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 MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM?

The FDA product code for MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM is DQX.

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Other records listing Intra Luminal Therapeutics, Inc. as applicant

K050916SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL]K050915SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]K040481SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1 K040037MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM K033929MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM K032031SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM

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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.