Cleared Traditional

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)

K240156 · Physio-Control, Inc. · Cardiovascular
Apr 2024
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K240156 is an FDA 510(k) clearance for the 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), a Cable, Transducer And Electrode, Patient, (including Connector) (Class II — Special Controls, product code DSA), submitted by Physio-Control, Inc. (Redmond, US). The FDA issued a Cleared decision on April 30, 2024, 102 days after receiving the submission on January 19, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2900.

Submission Details

510(k) Number K240156 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2024
Decision Date April 30, 2024
Days to Decision 102 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSA — Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2900

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