Device |
stabilizer, heart, non-compression, reprocessed |
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). |
Product Code | NQG |
Regulation Number |
870.4500
|
Device Class |
1
|
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