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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter,intravascular,therapeutic,long-term greater than 30 days
510(k) Number K121501
Models MC-42052-003,MC-42552-003,MC-43052-003, S-42041-002,S42541-002,S-43041-002
Device Name ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)
Original Applicant
ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
2400 bernville rd.
reading,  PA  19605
Original Contact julie lawson
Regulation Number880.5970
Classification Product Code
LJS  
Date Received05/21/2012
Decision Date 11/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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