Cardiogenesis Corporation

FDA Regulatory Profile

Cardiogenesis Corporation appears in FDA public data with 1 recall, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1993-2013, Class II) was initiated on May 1, 2011.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1993-2013Class IICardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use May 1, 2011