Cleared Traditional

K112404 - CONCENTRIC BALLOON GUIDE CATHETER

K112404 is an FDA 510(k) clearance for CONCENTRIC BALLOON GUIDE CATHETER, manufactured by Concentric Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K112404 · Concentric Medical, Inc. · Cardiovascular device
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Mar 2012
Decision
206d
Days
Class 2
Risk

K112404 is an FDA 510(k) clearance for the CONCENTRIC 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 March 15, 2012 after a review of 206 days - an extended review cycle.

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

FDA 510(k) Submission Details - K112404

510(k) Number K112404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2011
Decision Date March 15, 2012
Days to Decision 206 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 125d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQY Catheter, Percutaneous

All 782
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