NQG · Class I · 21 CFR 870.4500

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 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
1–3 of 3
Cleared Mar 15, 2007
REPROCESSED HEART STABILIZERS AND POSITIONERS
K063844
Sterilmed, Inc.
Cardiovascular · 79d

About Product Code NQG - Regulatory Context