Cleared Special

K071826 - THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910

K071826 is an FDA 510(k) clearance for THE RINSPIRATOR, manufactured by Fox Hollow Technologies. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Special 510(k) pathway after a 129-day FDA review.

K071826 · Fox Hollow Technologies · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
129d
Days
Class 2
Risk

K071826 is an FDA 510(k) clearance for the THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Fox Hollow Technologies (Redwood City, US). The FDA issued a Cleared decision on November 9, 2007 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K071826

510(k) Number K071826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2007
Decision Date November 09, 2007
Days to Decision 129 days
Submission Type Special
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
4d slower than avg
Panel avg: 125d · This submission: 129d
Pathway characteristics
Modification to existing cleared device.

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 94
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K071826.
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
K073441 · Possis Medical, Inc. · Jan 2008
PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010
K072810 · Vascular Solutions, Inc. · Dec 2007
ANGIOJET ULTRA
K072769 · Possis Medical, Inc. · Nov 2007
QXT EXTRACTION CATHETER
K071727 · Vascular Solutions, Inc. · Sep 2007
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552
K072269 · Possis Medical, Inc. · Sep 2007
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307
K071336 · Possis Medical, Inc. · Aug 2007
K071826 · THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910
Download PDF FDA Summary Fox Hollow Technologi…