Cleared Traditional

K914880 - DUAL BALLOON EMBOLECTOMY CATHETER

K914880 is the FDA 510(k) clearance for DUAL BALLOON EMBOLECTOMY CATHETER by Ideal Medical, Inc.. It is a Class 2 Cardiovascular device (product code DXE) cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K914880 · Ideal Medical, Inc. · Cardiovascular device
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Mar 1992
Decision
138d
Days
Class 2
Risk

K914880 is an FDA 510(k) clearance for the DUAL BALLOON EMBOLECTOMY CATHETER. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Ideal Medical, Inc. (Clearwater, US). The FDA issued a Cleared decision on March 16, 1992 after a review of 138 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 Ideal Medical, Inc. devices

Submission Details

510(k) Number K914880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1991
Decision Date March 16, 1992
Days to Decision 138 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 125d · This submission: 138d
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 27
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K914880.
ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025
K982141 · Arrow Intl., Inc. · Aug 1998
DCAT EMBOLECTOMY CATHETER SYSTEM
K971314 · AngioDynamics, Inc. · Mar 1998
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