Digital Angiography Tray
The Digital Angiography Tray (product code OFH) is a cardiovascular convenience kit containing components used during digital angiography procedures for vascular imaging. Established under the May 1997 FDA Convenience Kits Interim Regulatory Guidance, it is under enforcement discretion and does not require a 510(k) submission provided all guidance criteria are met. This device is FDA Class 2 under regulation 870.1650 in the Cardiovascular specialty. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OFH
- Device Class
- FDA class 2
- Regulation Number
- 870.1650
- 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 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.