Cardiovascular Surgical Instruments Tray
The Cardiovascular Surgical Instruments Tray (product code OFA) is a cardiovascular convenience kit containing surgical instruments packaged together for use in cardiovascular surgery. Established under the May 1997 FDA Convenience Kits Interim Regulatory Guidance, it is under enforcement discretion and does not require a premarket notification if all guidance criteria are met. This device is FDA Class 1 under regulation 870.4500 in the Cardiovascular specialty, subject only to general controls. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OFA
- Device Class
- FDA class 1
- Regulation Number
- 870.4500
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 7
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.