Catheter, Percutaneous, Cardiac Ablation, for Treatment of Atrial Flutter
Who Makes This Device Type in China?
2 manufacturers in China hold an FDA registration for this device type, based in Guangdong. All of them are contract manufacturers, able to build to a buyer’s own specification.
- Amphenol Alden Products Company Guangdong, contract manufacturer
- ATL Technology DG,Ltd. Guangdong, contract manufacturer
What Is This Device?
For the treatment of atrial flutter.
How Is OAD Classified?
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter is FDA product code OAD, Class 3.
How Does It Reach the US Market?
A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. No approval under this code names a Chinese applicant.
What Do the Recalls Say?
The FDA has recorded 22 recalls under this product code since 2009. None was by a company in China. 1 is Class I, the most serious grade.
The root causes the FDA records most often are Use error (6), Device Design (6) and Nonconforming Material/Component (3). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.