FDA 510(k)

SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING

K-Number: K073162 · 2008-02-08

Decision Date2008-02-08

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING is the device name listed in this FDA 510(k) record. The listed applicant is Kensey Nash Corporation. It received FDA 510(k) clearance on 2008-02-08 under 510(k) number K073162. 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(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING?

SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING is a medical device that received FDA 510(k) clearance on 2008-02-08. The listed applicant is Kensey Nash Corporation. The 510(k) number is K073162.

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

SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING received FDA 510(k) clearance on 2008-02-08, under 510(k) number K073162.

Who is the listed applicant for SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING?

The FDA 510(k) record lists Kensey Nash Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING?

The FDA product code for SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING is DQX.

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Other records listing Kensey Nash Corporation as applicant

K121310MESOTHELIUM DENTAL MEMBRANE K112888MESO WOUND MATRIX K094061KENSEY NASH ECM SURGICAL PATCH K060917KENSEY NASH BONE VOID FILLER K061030BIOBLANKET SURGICAL MESH

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.