Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)
FDA 510(k) clearance K233983 · decided 2024-06-27
Clearance details
- K-number
- K233983
- Device name
- Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)
- Applicant
- Edwards Lifesciences
- Decision
- Substantially Equivalent
- Date received
- 2023-12-18
- Decision date
- 2024-06-27
- Days to decision
- 192 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 Pacing Catheter, Models: D200F7; recall (Z-2204-2026) | Becton, Dickinson and Company | 2026-05-15 |