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
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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.

View all Fox Hollow Technologies devices

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
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 74
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K071826.
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K072269 · Possis Medical, Inc. · Sep 2007
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307
K071336 · Possis Medical, Inc. · Aug 2007