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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 K993442
Device Name VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR)
Applicant
Vygon Corp.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Applicant Contact ROBERT SCHIFF
Correspondent
Vygon Corp.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Correspondent Contact ROBERT SCHIFF
Regulation Number880.5970
Classification Product Code
LJS  
Date Received10/12/1999
Decision Date 08/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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