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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 K954638
Device Name 5 FR PICC-LINE CATHETER
Applicant
Vygon Corp.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Applicant Contact ANNE MARIE CESARIO
Correspondent
Vygon Corp.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Correspondent Contact ANNE MARIE CESARIO
Regulation Number880.5970
Classification Product Code
LJS  
Date Received10/06/1995
Decision Date 04/22/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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