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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K172410
Device Name Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters
Applicant
Smiths Medical Asd, Inc.
6000 Nathan Ln. N
Plymouth,  MN  55442
Applicant Contact Michael R. Johnson
Correspondent
Smiths Medical Asd, Inc.
6000 Nathan Ln. N
Plymouth,  MN  55442
Correspondent Contact Michael R. Johnson
Regulation Number868.5150
Classification Product Code
BSP  
Subsequent Product Codes
BSN   CAZ   MIA  
Date Received08/09/2017
Decision Date 06/01/2018
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
Recalls CDRH Recalls
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