EDWARDS PERIPHERAL DILATION CATHETER
FDA 510(k) clearance K052149 · decided 2005-09-02
Clearance details
- K-number
- K052149
- Device name
- EDWARDS PERIPHERAL DILATION CATHETER
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2005-08-08
- Decision date
- 2005-09-02
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- 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.