Cardiac Ablation Percutaneous Catheter
Which Manufacturers in China Make This?
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?
This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae].
How Is LPB Classified?
Cardiac Ablation Percutaneous Catheter is FDA product code LPB, Class 3.
What Does It Take to Sell It in the United States?
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 21 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Process control (6), Nonconforming Material/Component (2) and Use error (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.