Cleared Traditional

K152401 - Stingray LP Catheter

K152401 is the FDA 510(k) clearance for Stingray LP Catheter by Boston Scientific Corporation. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K152401 · Boston Scientific Corporation · Cardiovascular device
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Dec 2015
Decision
101d
Days
Class 2
Risk

K152401 is an FDA 510(k) clearance for the Stingray LP Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on December 4, 2015 after a review of 101 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 Boston Scientific Corporation devices

Submission Details

510(k) Number K152401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2015
Decision Date December 04, 2015
Days to Decision 101 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
24d faster than avg
Panel avg: 125d · This submission: 101d
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 581
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K152401.
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ASAHI Corsair Armet
K152249 · Asahi Intecc Co., Ltd. · Mar 2016
ASAHI Caravel
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Lantern Delivery Microcatheter
K152840 · Penumbra, Inc. · Dec 2015
AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm
K151667 · Stryker · Nov 2015
Selectra Catheters and Selectra Accessory Kit
K151409 · Biotronik, Inc. · Aug 2015