NQG

3 FDA 510(k) clearances · Product code

FDA profile

Official device name

Stabilizer, Heart, Non-Compression, Reprocessed

Device class

Class I (low risk)

Regulation

21 CFR 870.4500

Medical specialty

Cardiovascular

Flags

Third-party review eligible

FDA 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).

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free