Product code LXN— Cardiovascular
EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116
- Classification name
- Probe, Test, Heart-Valve
- Device class
- Class 1
- Regulation
- 21 CFR 870.4500
- Advisory panel
- Cardiovascular
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code LXN
FDA has cleared devices under product code LXN between 1988 and 1989, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1989
- 1988
Top applicants under product code LXN
Recent clearances under product code LXN
Data sourced from openFDA. This site is unofficial and independent of the FDA.