Cleared Special

K032376 - ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPH...

K032376 is the FDA 510(k) clearance for ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPH... by AngioDynamics, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Special 510(k) pathway after a 25-day FDA review.

K032376 · AngioDynamics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
25d
Days
Class 2
Risk

K032376 is an FDA 510(k) clearance for the ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on August 26, 2003 after a review of 25 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 AngioDynamics, Inc. devices

Submission Details

510(k) Number K032376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2003
Decision Date August 26, 2003
Days to Decision 25 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 125d · This submission: 25d
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 291
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K032376.
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K040830 · NuMED, Inc. · Jun 2004
ATLANTIS SR, MODEL C4020
K040776 · Boston Scientific Corp · Apr 2004
PROGREAT
K033583 · Terumo Medical Corp. · Dec 2003
ULTRA HIGH PRESSURE INJECTOR LINES
K023591 · Deroyal Industries, Inc. · Jun 2003
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
K024126 · Abbott Laboratories · Jan 2003
RENEGADE STC 18 MICROCATHETER
K023681 · Boston Scientific Corp · Nov 2002