Cleared Special

K081454 - GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE

K081454 is an FDA 510(k) clearance for GUARDDOG OCCLUSION GUIDEWIRE, manufactured by Possis Medical, Inc.. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Special 510(k) pathway after a 21-day FDA review.

K081454 · Possis Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
21d
Days
Class 2
Risk

K081454 is an FDA 510(k) clearance for the GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Possis Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 13, 2008 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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. Low regulatory complexity profile. 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 - K081454

510(k) Number K081454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2008
Decision Date June 13, 2008
Days to Decision 21 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
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

MJN Device Classification - Class 2, Special Controls

Product Code MJN Catheter, Intravascular Occluding, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - MJN Catheter, Intravascular Occluding, Temporary

All 89
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K081454.
HYPERGLIDE OCCLUSION BALLOON SYSTEM
K090728 · Ev3, Inc. · Apr 2009
DUOFLO CATHETER
K080700 · Thermopeutix, Inc. · Sep 2008
MICRUS ASCENT OCCLUSION BALLOON CATHETER
K080861 · Micrus Endovascular Corporation · Aug 2008
FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05
K071367 · LeMaitre Vascular, Inc. · Aug 2007
GORE BALLOON SHEATH
K070770 · W.L. Gore & Associates, Inc. · Jun 2007
MODIFICATION TO GUARDDOG OCCLUSION SYSTEM
K062220 · Possis Medical, Inc. · Aug 2006
K081454 · GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE
Download PDF FDA Summary Possis Medical, Inc.