OFH · Digital Angiography Tray
Cardiovascular · 21 CFR 870.1650 · Class 2
Overview
| Product Code | OFH |
|---|---|
| Device Name | Digital Angiography Tray |
| Regulation | 21 CFR 870.1650 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
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.
Special Controls
*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
