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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 K063363
Device Name FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE
Applicant
Flexicath , Ltd.
20 Hataas St.
P.O.B. 124
Kfar Saba,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
Flexicath , Ltd.
20 Hataas St.
P.O.B. 124
Kfar Saba,  IL 44425
Correspondent Contact AHAVA STEIN
Regulation Number880.5970
Classification Product Code
LJS  
Date Received11/07/2006
Decision Date 05/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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