Cleared Traditional

K032888 - CREATION NM DIAGNOSTIC CATHETERS

K032888 is an FDA 510(k) clearance for CREATION NM DIAGNOSTIC CATHETERS, manufactured by Neich Medical (Shenzhen) Company Limited. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K032888 · Neich Medical (Shenzhen) Company Limited · Cardiovascular device
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Feb 2004
Decision
161d
Days
Class 2
Risk

K032888 is an FDA 510(k) clearance for the CREATION NM DIAGNOSTIC CATHETERS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Neich Medical (Shenzhen) Company Limited (Shenzhen, CN). The FDA issued a Cleared decision on February 24, 2004 after a review of 161 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Neich Medical (Shenzhen) Company Limited devices

FDA 510(k) Submission Details - K032888

510(k) Number K032888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2003
Decision Date February 24, 2004
Days to Decision 161 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 125d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 305
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K032888.
VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP)
K041909 · Vascular Solutions, Inc. · Sep 2004
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
ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER
K032376 · AngioDynamics, Inc. · Aug 2003
ULTRA HIGH PRESSURE INJECTOR LINES
K023591 · Deroyal Industries, Inc. · Jun 2003