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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 K935145
Device Name CYPERFLO PERIPHERALLY INSERTED CATHETER
Applicant
Cyex Medical Technologies, Inc.
140 Renfrew Dr., Suite 205
Markham, Ontario,  CA L3R 6B3
Applicant Contact KATHERINE CREWE
Correspondent
Cyex Medical Technologies, Inc.
140 Renfrew Dr., Suite 205
Markham, Ontario,  CA L3R 6B3
Correspondent Contact KATHERINE CREWE
Regulation Number880.5970
Classification Product Code
LJS  
Date Received10/26/1993
Decision Date 03/09/1995
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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