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. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciences Research Medical
- Product code
- Code DTM
- Device class
- Class 2
- Regulation
- 21 CFR 870.4260
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Midvale, UT, US
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