DYG
- Product code
- DYG
- Device name
- Catheter, Flow Directed
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1240
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 99 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242451 | 2024-12-09 | Edwards Lifesciences | HemoSphere Alta Advanced Monitoring Platform (ALTAAL… | |
| K233983 | 2024-06-27 | Edwards Lifesciences | Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipo… | |
| K233824 | 2024-06-06 | Edwards Lifesciences, LLC | Swan-Ganz catheter | |
| K231248 | 2023-09-21 | Edwards Lifesciencess, LLC | Swan-Ganz Catheters, FloTrac sensors, ClearSight fin… |
Official FDA classification page: DYG
Classification and pathway per current FDA publications. Data from openFDA (CC0).