Cleared Traditional

K151667 - AXS Catalyst Distal Access Catheter 058...

K151667 is the FDA 510(k) clearance for AXS Catalyst Distal Access Catheter 058... by Stryker. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K151667 · Stryker · Cardiovascular device
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Nov 2015
Decision
147d
Days
Class 2
Risk

K151667 is an FDA 510(k) clearance for the AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Cat.... Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Stryker (Fremont, US). The FDA issued a Cleared decision on November 13, 2015 after a review of 147 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.

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Submission Details

510(k) Number K151667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2015
Decision Date November 13, 2015
Days to Decision 147 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
22d slower than avg
Panel avg: 125d · This submission: 147d
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 470
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K151667.
ASAHI Caravel
K152447 · Asahi Intecc Co., Ltd. · Jan 2016
Stingray LP Catheter
K152401 · Boston Scientific Corporation · Dec 2015
Lantern Delivery Microcatheter
K152840 · Penumbra, Inc. · Dec 2015
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