21 CFR 870.3450 — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cardiovascular (CV) · Part 870 Subpart D—Cardiovascular Prosthetic Devices · § 870.3450
Identification
A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 2 | 188 | Implant |
| DYF | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | 2 | 21 | Implant |
| MAB | Marker, Cardiopulmonary Bypass (Vein Marker) | 2 | 3 | |
| MAL | Graft, Vascular, Synthetic/Biologic Composite | 2 | 8 | Implant |
| MZY | Graft, Vascular, Stainless Steel Tunneler | 2 | 0 |
Special Controls
DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
eCFR
DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
Ecfr Llm
DYF — Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
eCFR
MAB — Marker, Cardiopulmonary Bypass (Vein Marker)
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
eCFR
MAL — Graft, Vascular, Synthetic/Biologic Composite
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
eCFR
MZY — Graft, Vascular, Stainless Steel Tunneler
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
eCFR
