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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, diagnostic
510(k) Number K213666
Device Name NuCath Wedge Pressure Catheter
Applicant
PFM Medical, Inc.
1916 Palomar Oaks Way Suite 150
Carlsbad,  CA  92008
Applicant Contact Jessica Jho
Correspondent
PFM Medical, Inc.
1916 Palomar Oaks Way Suite 150
Carlsbad,  CA  92008
Correspondent Contact Jessica Jho
Regulation Number870.1200
Classification Product Code
DQO  
Date Received11/22/2021
Decision Date 10/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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