Swan Ganz Catheters
FDA 510(k) clearance K160084 · decided 2016-05-03
Clearance details
- K-number
- K160084
- Device name
- Swan Ganz Catheters
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-01-15
- Decision date
- 2016-05-03
- Days to decision
- 109 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 |
|---|---|---|
| Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan recall (Z-0762-2019) | Edwards Lifesciences, LLC | 2019-01-31 |
| Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Produ recall (Z-0763-2019) | Edwards Lifesciences, LLC | 2019-01-31 |
| Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swa recall (Z-0764-2019) | Edwards Lifesciences, LLC | 2019-01-31 |
| Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan- recall (Z-0765-2019) | Edwards Lifesciences, LLC | 2019-01-31 |