MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS— 510(k) K864155
Substantially EquivalentAmerican Edwards Laboratories
FDA 510(k) clearance K864155 for MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS, Substantially Equivalent on 1986-11-20. Applicant: American Edwards Laboratories.
Clearance details
- Applicant
- American Edwards Laboratories
- Product code
- Code DTJ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.