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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 K071361
Device Name R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005
Applicant
R4 Vascular, Inc.
1246 University Ave. W.
Suite 438
St. Paul,  MN  55104
Applicant Contact MICHAEL SARAJIAN
Correspondent
R4 Vascular, Inc.
1246 University Ave. W.
Suite 438
St. Paul,  MN  55104
Correspondent Contact MICHAEL SARAJIAN
Regulation Number880.5970
Classification Product Code
LJS  
Date Received05/15/2007
Decision Date 08/20/2007
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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