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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 K171146
Device Name Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.
Applicant
Arrow International, Inc. (Subsidiary of Telelflex Inc.)
2400 Bernville Road
Reading,  PA  19605
Applicant Contact Fallon Young
Correspondent
Arrow International, Inc. (Subsidiary of Telelflex Inc.)
2400 Bernville Road
Reading,  PA  19605
Correspondent Contact Fallon Young
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/19/2017
Decision Date 06/23/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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