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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, conduction, anesthetic
510(k) Number K140110
Device Name FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET
Applicant
TELEFLEX, INC.
2400 BERNVILLE ROAD
READING,  PA  19605
Applicant Contact CHET JONES
Correspondent
TELEFLEX, INC.
2400 BERNVILLE ROAD
READING,  PA  19605
Correspondent Contact CHET JONES
Regulation Number868.5120
Classification Product Code
BSO  
Date Received01/15/2014
Decision Date 03/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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