FDA 510(k)

SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]

K-Number: K050915 · 2005-06-07

ApplicantIntra Luminal Therapeutics, Inc.

Decision Date2005-06-07

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY] 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 2005-06-07 under 510(k) number K050915. 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 SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]?

SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY] is a medical device that received FDA 510(k) clearance on 2005-06-07. The listed applicant is Intra Luminal Therapeutics, Inc.. The 510(k) number is K050915.

When did SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY] receive FDA 510(k) clearance?

SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY] received FDA 510(k) clearance on 2005-06-07, under 510(k) number K050915.

Who is the listed applicant for SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]?

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 SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]?

The FDA product code for SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY] is DQX.

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Other records listing Intra Luminal Therapeutics, Inc. as applicant

K050916SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL]K041973MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM 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.