Cleared Traditional

K090286 - PRESSUREMATE MANUAL FEMORAL ACCESS COMP...

K090286 is an FDA 510(k) clearance for PRESSUREMATE MANUAL FEMORAL ACCESS COMP..., manufactured by Advanced Vascular Dynamics. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K090286 · Advanced Vascular Dynamics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
46d
Days
Class 2
Risk

K090286 is an FDA 510(k) clearance for the PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Advanced Vascular Dynamics (Portland, US). The FDA issued a Cleared decision on March 23, 2009 after a review of 46 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. 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 Advanced Vascular Dynamics devices

FDA 510(k) Submission Details - K090286

510(k) Number K090286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2009
Decision Date March 23, 2009
Days to Decision 46 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
79d faster than avg
Panel avg: 125d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
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 - DXC Clamp, Vascular

All 94
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K090286.
MICROFRANCE(R) WORMALD VASCULAR CLAMP
K112662 · Medtronic Xomed, Inc. · Jan 2012
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
K113182 · Edwards Lifesciences, LLC · Dec 2011
EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER
K112694 · Edwards Lifesciences, LLC · Oct 2011
MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
K080206 · Radi Medical Systems AB · Feb 2008
TR BAND
K070423 · Terumo Medical Corp. · Mar 2007
D-STAT HANDLE, MODEL 8500-053
K063871 · Vascular Solutions, Inc. · Feb 2007