OER — Angioscopic Valvulotome Kit Class II
FDA product code OER covers "Angioscopic Valvulotome Kit", a Class II medical device regulated under 21 CFR 870.1650. Submissions are reviewed by the Cardiovascular panel.
Classification Details
- Product Code
- OER
- Device Class
- Class II
- Regulation Number
- 870.1650
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.