Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Guangdong. 1 is a contract manufacturer.
- Amphenol Medical Technologies (Dongguan) Co., Ltd. Guangdong, contract manufacturer
What Is It?
These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.
How Is NIK Classified?
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) is FDA product code NIK, 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 153 recalls under this product code since 2005. None was by a company in China. 72 are Class I, the most serious grade.
The root causes the FDA records most often are Software design (20), Device Design (10) and Nonconforming Material/Component (8). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.