Cleared Traditional

LATIS GRAFT CLEANING CATHETER

K973465 · Applied Medical Resources · Cardiovascular
Feb 1998
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K973465 is an FDA 510(k) clearance for the LATIS GRAFT CLEANING CATHETER, a Catheter, Embolectomy (Class II — Special Controls, product code DXE), submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on February 19, 1998, 160 days after receiving the submission on September 12, 1997. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K973465 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DXE — Catheter, Embolectomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5150

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