Medical Device Manufacturer · US , Tempe , AZ

Bard Peripheral Vascular, Inc. - FDA 510(k) Cleared Devices

34 submissions · 30 cleared · Since 2004

Total

Cleared

Denied

Bard Peripheral Vascular, Inc. is a medical device manufacturer based in Tempe, Arizona. The company specializes in cardiovascular and surgical devices for minimally invasive procedures.

FDA 510(k) regulatory activity spans from 2004 to 2026. The company has received 30 FDA 510(k) clearances from 34 total submissions. Cardiovascular devices represent a dominant category, including PTA balloons, atherectomy systems, and vascular access solutions. The company remains actively engaged in device development, with the latest clearance in 2026.

Recent cleared devices reflect expertise across multiple therapeutic areas. Products include percutaneous transluminal angioplasty balloons, breast biopsy and tissue removal systems, implantable ports, hemodialysis catheters, and drainage kits. This portfolio demonstrates broad capability in interventional cardiology, general surgery, and gastroenterology applications.

Explore the complete regulatory record, including specific device names, product codes, and individual clearance dates in the 510(k) database.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.

FDA 510(k) Regulatory Record - Bard Peripheral Vascular, Inc.

34 devices

1-12 of 34