Cleared Special

K152605 - Impulse Angiographic Catheter, Expo Angiographic Catheter

K152605 is an FDA 510(k) clearance for Impulse Angiographic Catheter, manufactured by Boston Scientific Corporation. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Special 510(k) pathway after a 48-day FDA review.

K152605 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
48d
Days
Class 2
Risk

K152605 is an FDA 510(k) clearance for the Impulse Angiographic Catheter, Expo Angiographic Catheter. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on October 29, 2015 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific Corporation devices

FDA 510(k) Submission Details - K152605

510(k) Number K152605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2015
Decision Date October 29, 2015
Days to Decision 48 days
Submission Type Special
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
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Modification to existing cleared device.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 406
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K152605.
Surefire Infusion System
K160662 · Surefire Medical, Inc. · Mar 2016
IntraNovo Microcatheter
K153125 · Texasmedical Technologies, Inc. · Jan 2016
Foresight Intracardiac Echocardiography (ICE) System
K151126 · Colibri Technologies, Inc. · Dec 2015
Radifocus Optitorque Angiographic Catheter
K150232 · Ashitaka Factory of Terumo Corp. · Oct 2015
AngioDynamics Mariner Angiographic Catheters
K151724 · AngioDynamics, Inc. · Oct 2015
Plato MICROCATH 27B Microcatheter
K143398 · Scientia Vascular, LLC · Jun 2015