OFB — Catheter Guide Wire Kit Class II
FDA product code OFB covers "Catheter Guide Wire Kit", a Class II medical device regulated under 21 CFR 870.1330. Submissions are reviewed by the Cardiovascular panel.
Classification Details
- Product Code
- OFB
- Device Class
- Class II
- Regulation Number
- 870.1330
- 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 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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.