FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
FDA 510(k) clearance K242909 · decided 2025-03-21
Clearance details
- K-number
- K242909
- Device name
- FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-09-24
- Decision date
- 2025-03-21
- Days to decision
- 178 days
- Clearance type
- Special
- Product code
- DRS
- Device class
- 2
- Regulation number
- 870.2850
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.