Cleared Special

K120893 - IMAGER II ANGIOGRAPHIC CATHETERS

K120893 is the FDA 510(k) clearance for IMAGER II ANGIOGRAPHIC CATHETERS by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Special 510(k) pathway after a 6-day FDA review.

K120893 · Boston Scientific Corp · Cardiovascular device
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Mar 2012
Decision
6d
Days
Class 2
Risk

K120893 is an FDA 510(k) clearance for the IMAGER II ANGIOGRAPHIC CATHETERS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on March 29, 2012 after a review of 6 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 Corp devices

Submission Details

510(k) Number K120893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2012
Decision Date March 29, 2012
Days to Decision 6 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
119d faster than avg
Panel avg: 125d · This submission: 6d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 247
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K120893.
HEADWAY DUO MICROCATHETER
K120917 · MicroVention, Inc. · Aug 2012
IMPULSE AND EXPO ANGIOGRAPHIC CATHETER
K120495 · Boston Scientific Corp · May 2012
ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS
K112452 · AngioDynamics, Inc. · Mar 2012
MERIT MARQUIS FLOW SWITCH
K110643 · Merit Medical Systems, Inc. · Jul 2011
EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER
K110103 · Edwards Lifesciences, LLC · Feb 2011
COHEN CROSSOVER CATHETER
K101625 · Vascular Solutions, Inc. · Jul 2010