Cleared Traditional

K050276 - DIVER C.E. CATHETER

K050276 is an FDA 510(k) clearance for DIVER C.E. CATHETER, manufactured by Invatec Innovative Technologies, S.R.L.. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K050276 · Invatec Innovative Technologies, S.R.L. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
28d
Days
Class 2
Risk

K050276 is an FDA 510(k) clearance for the DIVER C.E. CATHETER. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Invatec Innovative Technologies, S.R.L. (Plymouth, US). The FDA issued a Cleared decision on March 7, 2005 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Invatec Innovative Technologies, S.R.L. devices

FDA 510(k) Submission Details - K050276

510(k) Number K050276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2005
Decision Date March 07, 2005
Days to Decision 28 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QEZ Device Classification - Class 2, Special Controls

Product Code QEZ Aspiration Thrombectomy Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.
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 - QEZ Aspiration Thrombectomy Catheter

All 74
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K050276.
VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER
K051193 · Vascular Solutions, Inc. · Aug 2005
ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER
K050794 · Possis Medical, Inc. · Apr 2005
MODIFICATION TO: EXPORT CATHETER
K050139 · Medtronic Vascular · Mar 2005
MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
K042937 · Vascular Solutions, Inc. · Jan 2005
ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)
K042874 · Possis Medical, Inc. · Nov 2004
EXPORT CATHETER
K040869 · Medtronic Vascular · Jun 2004