Cleared Traditional

K131482 - SOFIA DISTAL ACCESS CATHETER

K131482 is the FDA 510(k) clearance for SOFIA DISTAL ACCESS CATHETER by MicroVention, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K131482 · MicroVention, Inc. · Cardiovascular device
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Nov 2013
Decision
183d
Days
Class 2
Risk

K131482 is an FDA 510(k) clearance for the SOFIA DISTAL ACCESS CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on November 22, 2013 after a review of 183 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 MicroVention, Inc. devices

Submission Details

510(k) Number K131482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2013
Decision Date November 22, 2013
Days to Decision 183 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 125d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - DQY Catheter, Percutaneous

All 482
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K131482.
TOTAL ACROSS
K133539 · Medtronic Vascular · Mar 2014
LEADLINER CS LEAD DELIVERY SYSTEM
K133501 · Vascular Solutions, Inc. · Feb 2014
ADVANCE CS CORONARY SINUS INFUSION CATHETER
K131204 · Cook, Inc. · Jan 2014
SHEATHLESS EAUCATH CORONARY GUIDE CATHETER
K132556 · Asahi Intecc Co., Ltd. · Oct 2013
5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER
K132673 · Medtronic, Inc. · Oct 2013
CONCIERGE GUIDING CATHETER
K132409 · Merit Medical Systems, Inc. · Aug 2013