510(k) K240156

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) by Physio-Control, Inc. — Product Code DSA

K240156 is an FDA 510(k) premarket notification submitted by Physio-Control, Inc. for the device "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)". The FDA issued a decision of Substantially Equivalent on April 30, 2024. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Physio-Control, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2024
Date Received
January 19, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type