Swan-Ganz Catheters
FDA 510(k) clearance K193466 · decided 2020-02-16
Clearance details
- K-number
- K193466
- Device name
- Swan-Ganz Catheters
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-12-16
- Decision date
- 2020-02-16
- Days to decision
- 62 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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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.