Stabilizer, Heart, Non-Compression, Reprocessed
FDA product code NQG · Class I (low risk) · 21 CFR 870.4500 · Cardiovascular
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).
3510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070036 | Reprocessed Medtronic Cardiac Stabilization and Positioning DevicesNQG · Traditional | Ascent Healthcare Solutions | 08/17/2007SE |
| K070034 | Reprocessed Guidant Cardiac Stabilization and Positioning DevicesNQG · Traditional | Ascent Healthcare Solutions | 08/17/2007SE |
| K063844 | Reprocessed Heart Stabilizers and PositionersNQG · Traditional | Sterilmed, Inc. | 03/15/2007SE |