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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K151667
Device Name AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm
Applicant
Stryker
47900 BAYSIDE PARKWAY
FREMONT,  CA  94538
Applicant Contact Rhoda M Santos
Correspondent
Stryker
47900 BAYSIDE PARKWAY
FREMONT,  CA  94538
Correspondent Contact Rhoda M Santos
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/19/2015
Decision Date 11/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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