EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE
FDA 510(k) clearance K031946 · decided 2003-11-03
Clearance details
- K-number
- K031946
- Device name
- EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2003-06-24
- Decision date
- 2003-11-03
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- DTM
- Device class
- 2
- Regulation number
- 870.4260
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Milpitas, 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.