Cleared Traditional

K130649 - SILK ROAD ACCESS CATHETER

K130649 is an FDA 510(k) clearance for SILK ROAD ACCESS CATHETER, manufactured by Silk Road Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K130649 · Silk Road Medical, Inc. · Cardiovascular device
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Nov 2013
Decision
235d
Days
Class 2
Risk

K130649 is an FDA 510(k) clearance for the SILK ROAD ACCESS CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Silk Road Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 1, 2013 after a review of 235 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 Silk Road Medical, Inc. devices

FDA 510(k) Submission Details - K130649

510(k) Number K130649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2013
Decision Date November 01, 2013
Days to Decision 235 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 125d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - DQY Catheter, Percutaneous

All 621
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K130649.
UNBALLOON NON-OCCLUSION MODELING CATHETER
K133026 · LeMaitre Vascular, Inc. · Dec 2013
SOFIA DISTAL ACCESS CATHETER
K131482 · MicroVention, Inc. · Nov 2013
TRANSGATE GUIDE CATHETER
K132542 · Stryker Neurovascular · Nov 2013
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
MODIFIED FLOWGATE BALLOON GUIDE CATHETER
K131492 · Concentric Medical, Inc. · Oct 2013