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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K851103
Device Name VASCULAR IMPLANT ACCESS NEEDLE SET
Applicant
Baxter Healthcare Corp
Londonderry Tpke.
Hooksett,  NH  03104
Applicant Contact ROGER A LEROUX
Correspondent
Baxter Healthcare Corp
Londonderry Tpke.
Hooksett,  NH  03104
Correspondent Contact ROGER A LEROUX
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/19/1985
Decision Date 07/16/1985
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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