NQG — Stabilizer, Heart, Non-Compression, Reprocessed Class I
Classification Details
- Product Code
- NQG
- Device Class
- Class I
- Regulation Number
- 870.4500
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K070034 | ascent healthcare solutions | REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES | August 17, 2007 |
| K070036 | ascent healthcare solutions | REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES | August 17, 2007 |
| K063844 | sterilmed | REPROCESSED HEART STABILIZERS AND POSITIONERS | March 15, 2007 |