Cleared Traditional

K051880 - RIO ASPIRATION CATHETER

K051880 is the FDA 510(k) clearance for RIO ASPIRATION CATHETER by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code QEZ) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K051880 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
177d
Days
Class 2
Risk

K051880 is an FDA 510(k) clearance for the RIO ASPIRATION CATHETER. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Boston Scientific Corp (Mountain View, US). The FDA issued a Cleared decision on January 4, 2006 after a review of 177 days - an extended review 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: 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 Boston Scientific Corp devices

Submission Details

510(k) Number K051880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2005
Decision Date January 04, 2006
Days to Decision 177 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
52d slower than avg
Panel avg: 125d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 50
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K051880.
PRONTO .035 EXTRACTION CATHETER
K070403 · Vascular Solutions, Inc. · Jun 2007
PRONTO V3 EXTRACTION CATHETER, MODEL 5003
K063371 · Vascular Solutions, Inc. · Dec 2006
MEDTRONIC EXPORT XT CATHETER
K061958 · Medtronic Vascular · Sep 2006
VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER
K052232 · Vascular Solutions, Inc. · Sep 2005
VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER
K051193 · Vascular Solutions, Inc. · Aug 2005
MODIFICATION TO: EXPORT CATHETER
K050139 · Medtronic Vascular · Mar 2005