Product code NKU— Cardiovascular
REPROCESSED BALOON INFLATION DEVICE
- Classification name
- Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code NKU
FDA has cleared device under product code NKU, all in 2006, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code NKU
Recent clearances under product code NKU
Data sourced from openFDA. This site is unofficial and independent of the FDA.