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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K780532
Device Name PERCUTANEOUS SHEATH INTRODUCER KIT
Original Applicant
ARROW INTL., INC.
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/04/1978
Decision Date 04/21/1978
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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