FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
FDA 510(k) K242909 · Edwards Lifesciences, LLC
510(k) numberK242909
Submission
- Device name
- FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
- Applicant
- Edwards Lifesciences, LLC
Irvine, CA, US - Received
- September 24, 2024
- Decision date
- March 21, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRS – Transducer, Blood-Pressure, Extravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2850
- Specialty
- Cardiovascular
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| K151040 | Art-line Single channel blood pressure system, Art-line Double channel blood pressure…DRS · Traditional | Biometrix , Ltd. | 09/04/2015SE |
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Questions and answers
When was FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors cleared by the FDA?
FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (K242909) received a 510(k) decision of Substantially Equivalent on March 21, 2025, 178 days after the submission was received.
What is the product code of K242909?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.