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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K240156
Device Name LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024)
Applicant
Physio-Control, Inc.
11811 Willows Rd. NE
Redmond,  WA  98052
Applicant Contact Elisha McGaff
Correspondent
Physio-Control, Inc.
11811 Willows Rd. NE
Redmond,  WA  98052
Correspondent Contact Elisha McGaff
Regulation Number870.2900
Classification Product Code
DSA  
Date Received01/19/2024
Decision Date 04/30/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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