RETROFLEX DILATOR KIT
FDA 510(k) clearance K093554 · decided 2010-04-13
Clearance details
- K-number
- K093554
- Device name
- RETROFLEX DILATOR KIT
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2009-11-17
- Decision date
- 2010-04-13
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- DRE
- Device class
- 2
- Regulation number
- 870.1310
- 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.