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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 K160925
FOIA Releasable 510(k) K160925
Device Name VPS Rhythm Device with TipTracker Technology
Applicant
ARROW INTERNATIONAL, INC. (A SUBSIDIARY OF TELEFLEX, INC.)
2400 BERNVILLE RD.
READING,  PA  19605
Applicant Contact KARL J. NITTINGER
Correspondent
ARROW INTERNATIONAL, INC. (A SUBSIDIARY OF TELEFLEX, INC.)
2400 BERNVILLE RD.
READING,  PA  19605
Correspondent Contact Christine Ford
Regulation Number880.5970
Classification Product Code
LJS  
Date Received04/04/2016
Decision Date 12/22/2016
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 No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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