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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Steerable
510(k) Number K112541
Device Name Z FLEX-270TM STEERABLE SHEATH
Applicant
Great Batch Medical
2300 Berkshire Lane N.
Pymouth,  MN  55441
Applicant Contact SARA BAKKER
Correspondent
Great Batch Medical
2300 Berkshire Lane N.
Pymouth,  MN  55441
Correspondent Contact SARA BAKKER
Regulation Number870.1280
Classification Product Code
DRA  
Date Received09/01/2011
Decision Date 02/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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