Cleared Traditional

K033436 - REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER

K033436 is an FDA 510(k) clearance for REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER, manufactured by Alliance Medical Corp.. The device is a Class 2 Cardiovascular device with product code OWQ cleared through the Traditional 510(k) pathway after a 505-day FDA review.

K033436 · Alliance Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
505d
Days
Class 2
Risk

K033436 is an FDA 510(k) clearance for the REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER. Classified as Reprocessed Intravascular Ultrasound Catheter (product code OWQ), Class II - Special Controls.

Submitted by Alliance Medical Corp. (Phoenix, US). The FDA issued a Cleared decision on March 16, 2005 after a review of 505 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Alliance Medical Corp. devices

FDA 510(k) Submission Details - K033436

510(k) Number K033436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2003
Decision Date March 16, 2005
Days to Decision 505 days
Submission Type Traditional
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
380d slower than avg
Panel avg: 125d · This submission: 505d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWQ Device Classification - Class 2, Special Controls

Product Code OWQ Reprocessed Intravascular Ultrasound Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
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 - OWQ Reprocessed Intravascular Ultrasound Catheter

All 26
Devices cleared under the same product code (OWQ) and FDA review panel - the closest regulatory comparables to K033436.
SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
K161700 · Sterilmed, Inc. · Nov 2016
Reprocessed Diagnostic Ultrasound Catheter
K153090 · Innovative Health, LLC · Mar 2016
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER
K110076 · Sterilmed, Inc. · Aug 2011
STERILEMED REPROCESSED IVUS IMAGING CATHETER
K043453 · Sterilmed, Inc. · Mar 2005
REPROCESSED IMAGING CATHETERS
K012537 · Sterilmed, Inc. · Oct 2002