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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 K231242
Device Name Perifix FX Catheter; Contiplex FX Catheter
Applicant
B.Braun Medical, Inc.
3773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact Tracy Larish
Correspondent
B.Braun Medical, Inc.
3773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact Tracy Larish
Regulation Number868.5120
Classification Product Code
BSO  
Subsequent Product Code
CAZ  
Date Received05/01/2023
Decision Date 09/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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