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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K021120
Device Name RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP
Applicant
Arrow Intl., Inc.
2400 Bernville Rd.
Reading,  PA  19605
Applicant Contact DEBBIE PEACOCK
Correspondent
Arrow Intl., Inc.
2400 Bernville Rd.
Reading,  PA  19605
Correspondent Contact DEBBIE PEACOCK
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/08/2002
Decision Date 05/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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