FDA: Balloon angioplasty catheters can reach market via 510(k) route

09/13/2010 | Medical Devices Today

The FDA issued a ruling saying manufacturers of balloon-tipped coronary angioplasty catheters can bring these products to market via the 510(k) process, rather than the premarket approval procedure, effective Oct. 8. The move is in line with the agency's decision to reclassify percutaneous transluminal coronary angioplasty catheters from Class III to Class II devices with corresponding special requirements.

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