NCA · Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)
General, Plastic Surgery · 21 CFR 878.4300 · Class 2
Overview
| Product Code | NCA |
|---|---|
| Device Name | Clip, Implantable, For Coronary Artery Bypass Graft (Cabg) |
| Regulation | 21 CFR 878.4300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.
Classification Rationale
Class II.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K013664 | COALESCENT SURGICAL U-CLIP | Coalescent Surgical | Jan 24, 2002 | SESE |
| K011589 | 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 | Bypass , Ltd. | Dec 26, 2001 | SESE |
| K003446 | SYMMETRY AORTIC CLIP SYSTEM | St. Jude Medical Cardiovascular Group, Inc. | May 21, 2001 | SESE |
Top Applicants
- Bypass , Ltd. — 1 clearance
- Coalescent Surgical — 1 clearance
- St. Jude Medical Cardiovascular Group, Inc. — 1 clearance
