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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, Non-Implanted
510(k) Number K993933
Device Name 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO
Applicant
Arrow Intl., Inc.
2400 Bernville Rd.
Reading,  PA  19605
Applicant Contact THOMAS D NICKEL
Correspondent
Arrow Intl., Inc.
2400 Bernville Rd.
Reading,  PA  19605
Correspondent Contact THOMAS D NICKEL
Regulation Number876.5540
Classification Product Code
MPB  
Date Received11/18/1999
Decision Date 09/14/2000
Decision Substantially Equivalent (SESE)
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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