Product code NQG— Cardiovascular
REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES
- Classification name
- Stabilizer, Heart, Non-Compression, Reprocessed
- Device class
- Class 1
- Regulation
- 21 CFR 870.4500
- Advisory panel
- Cardiovascular
- Total cleared
- 3
- First cleared
- Most recent
FDA classification definition
“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).”
Market context for product code NQG
FDA has cleared devices under product code NQG, all in 2007, 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.
Top applicants under product code NQG
Recent clearances under product code NQG
Data sourced from openFDA. This site is unofficial and independent of the FDA.