NQG

Stabilizer, Heart, Non-Compression, Reprocessed

Product code

NQG

Device name

Stabilizer, Heart, Non-Compression, Reprocessed

Device class

Class 1

21 CFR

21 CFR 870.4500

Medical specialty

Cardiovascular

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).