K131492 is an FDA 510(k) clearance for the MODIFIED FLOWGATE BALLOON GUIDE CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.
Submitted by Concentric Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on October 3, 2013 after a review of 133 days - within the typical 510(k) review window.
This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.
View all Concentric Medical, Inc. devices
NCT00318071
Completed
Interventional
Industry-sponsored
Multi MERCI (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])
A Multinational Controlled Registry to Evaluate the Concentric Merci Retriever System (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])
| Condition studied |
Ischemic Stroke |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Wade S Smith, MD, PhD |
| Sponsor |
Stryker Neurovascular
(industry)
|
Started 2004-01-01
→
Primary completion 2006-12-01
Primary outcome
Revascularization success; Rates of device-related serious adverse events
Secondary outcome
modified Rankin scores
Study completed - no results published.
This trial concluded in 2006 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov