Cleared Special

K120495 - IMPULSE AND EXPO ANGIOGRAPHIC CATHETER

K120495 is an FDA 510(k) clearance for IMPULSE AND EXPO ANGIOGRAPHIC CATHETER, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Special 510(k) pathway after a 94-day FDA review.

K120495 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
94d
Days
Class 2
Risk

K120495 is an FDA 510(k) clearance for the IMPULSE AND EXPO ANGIOGRAPHIC CATHETER. 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 May 21, 2012 after a review of 94 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K120495

510(k) Number K120495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2012
Decision Date May 21, 2012
Days to Decision 94 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
31d faster than avg
Panel avg: 125d · This submission: 94d
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 469
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K120495.
HEARTRAIL III GUIDING CATHETER
K113335 · Terumo Corporation · Jul 2012
MONGOOSE ANGIOGRAPHIC CATHETER
K113819 · Pediacath, Inc. · Jul 2012
SUREFIRE HI-FLOW MICROCATHETER
K121677 · Surefire Medical, Inc. · Jun 2012
ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS
K112452 · AngioDynamics, Inc. · Mar 2012
IMAGER II ANGIOGRAPHIC CATHETERS
K120893 · Boston Scientific Corp · Mar 2012
MODIFIED CONCENTIRC MICROCATHETER
K113260 · Concentric Medical, Inc. · Mar 2012
K120495 · IMPULSE AND EXPO ANGIOGRAPHIC CATHETER
Download PDF FDA Summary Boston Scientific Corp