Cleared Traditional

K892410 - FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER

K892410 is an FDA 510(k) clearance for FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER, manufactured by Baxter Healthcare Corp. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K892410 · Baxter Healthcare Corp · Cardiovascular device
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Jul 1989
Decision
104d
Days
Class 2
Risk

K892410 is an FDA 510(k) clearance for the FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on July 20, 1989 after a review of 104 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.

FDA 510(k) Submission Details - K892410

510(k) Number K892410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1989
Decision Date July 20, 1989
Days to Decision 104 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 125d · This submission: 104d
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 73
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K892410.
REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER
K894681 · Shiley, Inc. · Oct 1989
TRI-LUMEN INTRA VASCULAR BALLOON CATHETER
K891021 · Ideal Medical, Inc. · Sep 1989
SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.
K893680 · Cathlab Corp. · Aug 1989
EMBOLECTOMY CATHETER(MODIFIED)
K881455 · Cathlab Corp. · Jun 1988
CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)
K872485 · Ideas For Medicine, Inc. · Aug 1987
PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED)
K864062 · Ideas For Medicine, Inc. · Jan 1987
K892410 · FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER
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