FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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)
K Number: K240156
·
Decision Apr 30, 2024
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
104
Applicant Total
14
Review Days
102
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Basic Information
- 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)
- K Number
- K240156
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Physio-Control, Inc.
- Date Received
- January 19, 2024
- Decision Date
- April 30, 2024
- Product Code
- DSA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | FDA class 2 | Cardiovascular |
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Other Clearances by Physio-Control, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253099 | LIFEPAK 15 AC Power Adapter (41577-000333) | Oct 14, 2025 | Substantially Equivalent |
| K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors | Jun 3, 2019 | Substantially Equivalent |
| K142430 | LIFEPAK 15 monitor/defibrillator | Dec 19, 2014 | Substantially Equivalent |
| K130454 | LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR | Aug 21, 2013 | Substantially Equivalent |
| K123597 | TRUECPR COACHING DEVICE | Apr 17, 2013 | Substantially Equivalent |
| K122600 | LIFEPAK 1000 DEFIBRILLATOR | Oct 11, 2012 | Substantially Equivalent |
| K103567 | LIFEPAK 15 MONITOR/DEFIBRILLATOR | Mar 22, 2011 | Substantially Equivalent |
| K102972 | LIFEPAK 12 | Dec 22, 2010 | Substantially Equivalent |
| K102757 | LIFENET SYSTEM | Nov 5, 2010 | Substantially Equivalent |
| K093925 | LIFENET SYSTEM | Jan 12, 2010 | Substantially Equivalent |