UltraScore Focused Force PTA Balloon
K-Number: K163420 · 2017-06-14
Device Summary
Frequently Asked Questions
What is the UltraScore Focused Force PTA Balloon?
UltraScore Focused Force PTA Balloon is a medical device that received FDA 510(k) clearance on 2017-06-14. The listed applicant is Bard Peripheral Vascular, Inc.. The 510(k) number is K163420.
When did UltraScore Focused Force PTA Balloon receive FDA 510(k) clearance?
UltraScore Focused Force PTA Balloon received FDA 510(k) clearance on 2017-06-14, under 510(k) number K163420.
Who is the listed applicant for UltraScore Focused Force PTA Balloon?
The FDA 510(k) record lists Bard Peripheral Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UltraScore Focused Force PTA Balloon?
The FDA product code for UltraScore Focused Force PTA Balloon is PNO.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Other records listing Bard Peripheral Vascular, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: PNO)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.