Cleared Traditional

K950586 - AVD INTIMAX THROMBECTOMY CATHETER

K950586 is an FDA 510(k) clearance for AVD INTIMAX THROMBECTOMY CATHETER, manufactured by Applied Medical Resources. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K950586 · Applied Medical Resources · Cardiovascular device
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May 1995
Decision
95d
Days
Class 2
Risk

K950586 is an FDA 510(k) clearance for the AVD INTIMAX THROMBECTOMY CATHETER. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on May 15, 1995 after a review of 95 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. 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 Applied Medical Resources devices

FDA 510(k) Submission Details - K950586

510(k) Number K950586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1995
Decision Date May 15, 1995
Days to Decision 95 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
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXE Device Classification - Class 2, Special Controls

Product Code DXE Catheter, Embolectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 - DXE Catheter, Embolectomy

All 38
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K950586.
LATIS GRAFT CLEANING CATHETER
K973465 · Applied Medical Resources · Feb 1998
DUAL LUMEN EMBOLECTOMY CATHETER
K970762 · Applied Medical Resources · Mar 1997
NEEDLE'S EYE SNARE
K961992 · Cook Pacemaker Corp. · Dec 1996
WELTER SNARE RETRIEVER
K920823 · Cook, Inc. · Mar 1993
INTIMAX THROMBECTOMY CATHETER
K910372 · Applied Vascular Devices, Inc. · Apr 1991
ARTERIAL EMBOLECTOMY CATHETER
K901627 · Applied Vascular Devices, Inc. · Oct 1990