FDA Product Code NQG: Stabilizer, Heart, Non-compression, Reprocessed
The Device Is Used To Stabilize, Move, Lift, And Position The Heart During Cardiovascular Surgery. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
Leading manufacturers include Ascent Healthcare Solutions and Sterilmed, Inc..
3
Total
3
Cleared
177d
Avg days
2007
Since
FDA 510(k) Cleared Stabilizer, Heart, Non-compression, Reprocessed Devices (Product Code NQG)
3 devices
Cleared
Aug 17, 2007
REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES
Ascent Healthcare Solutions
Cardiovascular
226d
Cleared
Aug 17, 2007
REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES
Ascent Healthcare Solutions
Cardiovascular
226d
Cleared
Mar 15, 2007
REPROCESSED HEART STABILIZERS AND POSITIONERS
Sterilmed, Inc.
Cardiovascular
79d