FDA product code NQG: Stabilizer, Heart, Non-Compression, Reprocessed
NQG is the FDA product code for stabilizer, heart, non-compression, reprocessed. It is a Class I device, regulated under 21 CFR 870.4500 and reviewed by the Cardiovascular panel. FDA has cleared 3 510(k) submissions under NQG, from 2 different applicants. The average 510(k) review took 177 days (median 226).
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).
Classification
| Field | Value |
|---|---|
| Device name | Stabilizer, Heart, Non-Compression, Reprocessed |
| Device class | Class I |
| Regulation | 21 CFR 870.4500 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NQG clearance
Top NQG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ascent Healthcare Solutions | 2 | 2007-08-17 |
| Sterilmed, Inc. | 1 | 2007-03-15 |
Most recent NQG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K070036 | Ascent Healthcare Solutions | REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES | 2007-08-17 | 226 |
| K070034 | Ascent Healthcare Solutions | REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES | 2007-08-17 | 226 |
| K063844 | Sterilmed, Inc. | REPROCESSED HEART STABILIZERS AND POSITIONERS | 2007-03-15 | 79 |
Recalls for NQG devices
openFDA lists no recalls for product code NQG.
Frequently asked questions
What is FDA product code NQG?
NQG is the FDA product code for stabilizer, heart, non-compression, reprocessed. It is a Class I device, regulated under 21 CFR 870.4500 and reviewed by the Cardiovascular panel.
What device class is NQG?
Class I, regulation 21 CFR 870.4500. Typical premarket route: 510(k).
How long does a 510(k) take for product code NQG?
Across 3 cleared submissions the average was 177 days from receipt to decision (median 226).
Which companies have the most NQG clearances?
Ascent Healthcare Solutions (2); Sterilmed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NQG
- Run a recall and safety report across every NQG manufacturer
- Watch product code NQG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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