Cleared Traditional

K973465 - LATIS GRAFT CLEANING CATHETER

K973465 is an FDA 510(k) clearance for LATIS GRAFT CLEANING 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 160-day FDA review.

K973465 · Applied Medical Resources · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
160d
Days
Class 2
Risk

K973465 is an FDA 510(k) clearance for the LATIS GRAFT CLEANING 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 February 19, 1998 after a review of 160 days - an extended review 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: 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 - K973465

510(k) Number K973465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1997
Decision Date February 19, 1998
Days to Decision 160 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
35d slower than avg
Panel avg: 125d · This submission: 160d
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 K973465.
ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
K002627 · Atrium Medical Corp. · Apr 2001
ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025
K982141 · Arrow Intl., Inc. · Aug 1998
DCAT EMBOLECTOMY CATHETER SYSTEM
K971314 · AngioDynamics, Inc. · Mar 1998
DUAL LUMEN EMBOLECTOMY CATHETER
K970762 · Applied Medical Resources · Mar 1997
NEEDLE'S EYE SNARE
K961992 · Cook Pacemaker Corp. · Dec 1996
AVD INTIMAX THROMBECTOMY CATHETER
K950586 · Applied Medical Resources · May 1995