Edwards Pressure Cable
FDA 510(k) clearance K191089 · decided 2019-06-13
Clearance details
- K-number
- K191089
- Device name
- Edwards Pressure Cable
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-04-24
- Decision date
- 2019-06-13
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- 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
No recalls on record reference this clearance.