21 CFR 870.3800 — Ring, Annuloplasty
Cardiovascular (CV) · Part 870 Subpart D—Cardiovascular Prosthetic Devices · § 870.3800
Identification
An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KRH | Ring, Annuloplasty | 2 | 74 | Implant |
| PST | Aortic Annuloplasty Ring | 2 | 2 | Implant, Life-Sustaining |
Special Controls
KRH — Ring, Annuloplasty
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”
eCFR
KRH — Ring, Annuloplasty
The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”
Ecfr Llm
PST — Aortic Annuloplasty Ring
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”
eCFR
