FDA 510(k) Application Details - K022061

Device Classification Name Catheter, Percutaneous

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510(K) Number K022061
Device Name Catheter, Percutaneous
Applicant CRYO VASCULAR SYSTEMS INC.
160 KNOWLES DR.
LOS GATOS, CA 95032 US
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Contact R. MICHAEL CROMPTON
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 06/25/2002
Decision Date 09/20/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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