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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K871080
Device Name PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
Applicant
CATHETER TECHNOLOGY CORP.
3385 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Applicant Contact COLIN J NICHOLS
Correspondent
CATHETER TECHNOLOGY CORP.
3385 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Correspondent Contact COLIN J NICHOLS
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/18/1987
Decision Date 08/12/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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