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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Hemodialysis, Triple Lumen, Non-Implanted
510(k) Number K143102
Device Name Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions
Applicant
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
2400 Bernville Rd.
Reading,  PA  19605
Applicant Contact Debra Grodt
Correspondent
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
2400 Bernville Rd.
Reading,  PA  19605
Correspondent Contact Karl J Nittinger
Regulation Number876.5540
Classification Product Code
NIE  
Date Received10/29/2014
Decision Date 07/24/2015
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
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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