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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 K001901
Device Name POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135
Applicant
C.R. Bard, Inc.
5425 W. Amelia Earhart Dr.
Salt Lake City,  UT  84116
Applicant Contact MICHAELA RIVKOWICH
Correspondent
C.R. Bard, Inc.
5425 W. Amelia Earhart Dr.
Salt Lake City,  UT  84116
Correspondent Contact MICHAELA RIVKOWICH
Regulation Number880.5970
Classification Product Code
LJS  
Date Received06/22/2000
Decision Date 09/19/2000
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
Recalls CDRH Recalls
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