MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH— 510(k) K062429
Substantially EquivalentEdwards Lifesciences Research Medical
FDA 510(k) clearance K062429 for MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH, Substantially Equivalent on 2006-09-27. Applicant: Edwards Lifesciences Research Medical.
Clearance details
- Applicant
- Edwards Lifesciences Research Medical
- Product code
- Code DTM
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Midvale, UT, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.