FDA 510(k) Cardiovascular Devices

About Cardiovascular Devices

FDA 510(k) cardiovascular devices represent one of the largest device categories, with 17,947 submissions since 1976. The FDA review panel code is CV.

This category covers a wide risk spectrum:

• Class I / II - blood pressure monitors, stethoscopes, ECG systems, holter monitors
• Class II Special Controls - catheters, guidewires, cardiac ablation systems
• Class II / III - pacemakers, implantable defibrillators, stents

Top product codes include DXN (blood pressure systems, 1,201 devices) and DQY (percutaneous catheters, 850 devices). Average FDA review time: 125 days.