ALVUE Balloon Dilation System
K-Number: K171939 · 2018-03-07
Device Summary
Frequently Asked Questions
What is the ALVUE Balloon Dilation System?
ALVUE Balloon Dilation System is a medical device that received FDA 510(k) clearance on 2018-03-07. The listed applicant is Globus Medical, Inc.. The 510(k) number is K171939.
When did ALVUE Balloon Dilation System receive FDA 510(k) clearance?
ALVUE Balloon Dilation System received FDA 510(k) clearance on 2018-03-07, under 510(k) number K171939.
Who is the listed applicant for ALVUE Balloon Dilation System?
The FDA 510(k) record lists Globus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ALVUE Balloon Dilation System?
The FDA product code for ALVUE Balloon Dilation System is GCJ.
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 Globus Medical, 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: GCJ)
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.