FDA product code NCA: Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)
NCA is the FDA product code for clip, implantable, for coronary artery bypass graft (cabg). It is a Class II device, regulated under 21 CFR 878.4300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under NCA, from 3 different applicants. The average 510(k) review took 164 days (median 196).
Classification
| Field | Value |
|---|---|
| Device name | Clip, Implantable, For Coronary Artery Bypass Graft (Cabg) |
| Device class | Class II |
| Regulation | 21 CFR 878.4300 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Top NCA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Coalescent Surgical | 1 | 2002-01-24 |
| Bypass , Ltd. | 1 | 2001-12-26 |
| St. Jude Medical Cardiovascular Group, Inc. | 1 | 2001-05-21 |
Most recent NCA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K013664 | Coalescent Surgical | COALESCENT SURGICAL U-CLIP | 2002-01-24 | 79 |
| K011589 | Bypass , Ltd. | CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M | 2001-12-26 | 217 |
| K003446 | St. Jude Medical Cardiovascular Group, Inc. | SYMMETRY AORTIC CLIP SYSTEM | 2001-05-21 | 196 |
Recalls for NCA devices
openFDA lists no recalls for product code NCA.
Frequently asked questions
What is FDA product code NCA?
NCA is the FDA product code for clip, implantable, for coronary artery bypass graft (cabg). It is a Class II device, regulated under 21 CFR 878.4300 and reviewed by the General and Plastic Surgery panel.
What device class is NCA?
Class II, regulation 21 CFR 878.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code NCA?
Across 3 cleared submissions the average was 164 days from receipt to decision (median 196).
Which companies have the most NCA clearances?
Coalescent Surgical (1); Bypass , Ltd. (1); St. Jude Medical Cardiovascular Group, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NCA
- Run a recall and safety report across every NCA manufacturer
- Watch product code NCA 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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