Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
FDA 510(k) clearance K231248 · decided 2023-09-21
Clearance details
- K-number
- K231248
- Device name
- Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
- Applicant
- Edwards Lifesciencess, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-05-01
- Decision date
- 2023-09-21
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- DYG
- Device class
- 2
- Regulation number
- 870.1240
- 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 |
|---|---|---|
| Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144 recall (Z-2202-2026) | Becton, Dickinson and Company | 2026-05-15 |
| Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P recall (Z-2203-2026) | Becton, Dickinson and Company | 2026-05-15 |