Cleared Traditional

K143459 - Silk Road Acccess Catheter

K143459 is an FDA 510(k) clearance for Silk Road Acccess 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 118-day FDA review.

K143459 · Silk Road Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
118d
Days
Class 2
Risk

K143459 is an FDA 510(k) clearance for the Silk Road Acccess 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 April 1, 2015 after a review of 118 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 Silk Road Medical, Inc. devices

FDA 510(k) Submission Details - K143459

510(k) Number K143459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2014
Decision Date April 01, 2015
Days to Decision 118 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
7d faster than avg
Panel avg: 125d · This submission: 118d
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 K143459.
Selectra Catheters and Selectra Accessory Kit
K151409 · Biotronik, Inc. · Aug 2015
ASAHI Corsair Microcatheter
K151103 · Asahi Intecc Co., Ltd. · Jun 2015
Coda LP Balloon Catheter
K150970 · Cook Incorporated · May 2015
SOFIA 6F Catheter
K150366 · MicroVention, Inc. · Mar 2015
Headway 27 Microcatheter
K142449 · MicroVention, Inc. · Mar 2015
ASAHI FUBUKI 043 / ASAHI FUBUKI
K141981 · Asahi Intecc Co., Ltd. · Mar 2015