Cleared Traditional

K914880 - DUAL BALLOON EMBOLECTOMY CATHETER

K914880 is an FDA 510(k) clearance for DUAL BALLOON EMBOLECTOMY CATHETER, manufactured by Ideal Medical, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K914880

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.

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 57
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K914880.
AVD INTIMAX THROMBECTOMY CATHETER
K950586 · Applied Medical Resources · May 1995
ARTERIAL EMBOLECTOMY
K935405 · J-Lloyd Medical, Inc. · Jul 1994
WELTER SNARE RETRIEVER
K920823 · Cook, Inc. · Mar 1993
INTIMAX THROMBECTOMY CATHETER
K910372 · Applied Vascular Devices, Inc. · Apr 1991
AMPLATZ GOOSE-NECK SNARE
K901502 · Microvena Corp. · Dec 1990
ARTERIAL EMBOLECTOMY CATHETER
K901627 · Applied Vascular Devices, Inc. · Oct 1990