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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 K072391
Device Name PFM PICC
Applicant
Pfm Medical, Inc.
2605 Temple Heights Dr.
Suite A
Oceanside,  CA  92056
Applicant Contact SALVADORE PALOMARES
Correspondent
Pfm Medical, Inc.
2605 Temple Heights Dr.
Suite A
Oceanside,  CA  92056
Correspondent Contact SALVADORE PALOMARES
Regulation Number880.5970
Classification Product Code
LJS  
Date Received08/24/2007
Decision Date 11/19/2007
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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