Cleared Traditional

K910372 - INTIMAX THROMBECTOMY CATHETER

K910372 is the FDA 510(k) clearance for INTIMAX THROMBECTOMY CATHETER by Applied Vascular Devices, Inc.. It is a Class 2 Cardiovascular device (product code DXE) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K910372 · Applied Vascular Devices, Inc. · Cardiovascular device
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Apr 1991
Decision
87d
Days
Class 2
Risk

K910372 is an FDA 510(k) clearance for the INTIMAX THROMBECTOMY CATHETER. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Applied Vascular Devices, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on April 26, 1991 after a review of 87 days - a notably fast clearance cycle.

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: 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 Applied Vascular Devices, Inc. devices

Submission Details

510(k) Number K910372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1991
Decision Date April 26, 1991
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 36
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K910372.
NEEDLE'S EYE SNARE
K961992 · Cook Pacemaker Corp. · Dec 1996
AVD INTIMAX THROMBECTOMY CATHETER
K950586 · Applied Medical Resources · May 1995
WELTER SNARE RETRIEVER
K920823 · Cook, Inc. · Mar 1993
FOGARTY ARTERIAL EMBOLECTOMY II CATHETER
K901625 · Baxter Healthcare Corp · Jul 1990
REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER
K894681 · Shiley, Inc. · Oct 1989
FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER
K892410 · Baxter Healthcare Corp · Jul 1989