DRS
- Product code
- DRS
- Device name
- Transducer, Blood-Pressure, Extravascular
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.2850
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 148
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242909 | 2025-03-21 | Edwards Lifesciences, LLC | FloTrac sensors; FloTrac Jr sensors; Acumen IQ senso |
Official FDA classification page: DRS
Classification and pathway per current FDA publications. Data from openFDA (CC0).