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Stabilizer, Heart, Non-Compression, Reprocessed

FDA product code NQG · 3 cleared devices

Class 1 Cardiovascular
Regulation
21 CFR 870.4500
Review panel
CV
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2007-03-15 – 2007-08-17

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).

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