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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K112896
Device Name ARRW EVOLUTION
Applicant
Arrow International (Subsidiary of Teleflex Inc.)
2400 Bernville Rd.
Reading,  PA  19605
Applicant Contact TRACY MADDOCK
Correspondent
Arrow International (Subsidiary of Teleflex Inc.)
2400 Bernville Rd.
Reading,  PA  19605
Correspondent Contact TRACY MADDOCK
Regulation Number880.5970
Classification Product Code
LJS  
Date Received09/30/2011
Decision Date 05/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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