Product code NDQ— Cardiovascular
CRONUS GUIDEWIRE, MODEL 001-001470-1
- Classification name
- System, Catheter Or Guidewire, Steerable (Magnetic)
- Device class
- Class 2
- Regulation
- 21 CFR 870.1290
- Advisory panel
- Cardiovascular
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code NDQ
FDA has cleared devices under product code NDQ between 2005 and 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.
Clearances per year
- 2006
- 2005
Top applicants under product code NDQ
Recent clearances under product code NDQ
Data sourced from openFDA. This site is unofficial and independent of the FDA.