Flo Trac sensor, Volume View sensor
FDA 510(k) clearance K152980 · decided 2016-01-19
Clearance details
- K-number
- K152980
- Device name
- Flo Trac sensor, Volume View sensor
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-10-09
- Decision date
- 2016-01-19
- Days to decision
- 102 days
- Clearance type
- Traditional
- 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, S recall (Z-0409-2024) | Edwards Lifesciences, LLC | 2023-11-29 |
| Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use i recall (Z-0410-2024) | Edwards Lifesciences, LLC | 2023-11-29 |
| FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For us recall (Z-0411-2024) | Edwards Lifesciences, LLC | 2023-11-29 |
| FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For us recall (Z-0412-2024) | Edwards Lifesciences, LLC | 2023-11-29 |