TRIPLE LUMEN PFM PICC


Device Classification Name

catheter,intravascular,therapeutic,long-term greater than 30 days

510(k) Number K110914
Device Name TRIPLE LUMEN PFM PICC
Applicant
PFM MEDICAL, INC
1815 aston ave
suite 106
carlsbad, 
CA 
92008

Applicant Contact salvadore palomares
Correspondent
PFM MEDICAL, INC
1815 aston ave
suite 106
carlsbad, 
CA 
92008

Correspodent Contact salvadore palomares
Regulation Number 880.5970
Classification Product Code
LJS  
Date Received 04/01/2011
Decision Date 09/21/2011
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