Cleared Traditional

K152401 - Stingray LP Catheter

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

K152401 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K152401

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.

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 785
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K152401.
Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm
K152202 · Tni Manufacturing, Inc. · Dec 2015
MIVI Mi-AXUS Guide Catheter
K151396 · Mivi Neuroscience, Inc. · Dec 2015
Houdini Catheter
K151896 · Cruzar Medsystems, Inc. · Dec 2015
Lantern Delivery Microcatheter
K152840 · Penumbra, Inc. · Dec 2015
Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter
K151638 · Cathera, Inc. · Nov 2015
AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm
K151667 · Stryker · Nov 2015