Cleared Traditional

K891021 - TRI-LUMEN INTRA VASCULAR BALLOON CATHETER

K891021 is an FDA 510(k) clearance for TRI-LUMEN INTRA VASCULAR BALLOON 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 202-day FDA review.

K891021 · Ideal Medical, Inc. · Cardiovascular device
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Sep 1989
Decision
202d
Days
Class 2
Risk

K891021 is an FDA 510(k) clearance for the TRI-LUMEN INTRA VASCULAR BALLOON 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 September 18, 1989 after a review of 202 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 Ideal Medical, Inc. devices

FDA 510(k) Submission Details - K891021

510(k) Number K891021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1989
Decision Date September 18, 1989
Days to Decision 202 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 125d · This submission: 202d
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 K891021.
ARTERIAL EMBOLECTOMY CATHETER
K900311 · Impra, Inc. · Jul 1990
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
SHEAR FORCE GAUGE
K864330 · American Edwards Laboratories · Jan 1987
EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER
K864007 · Uresil Corp. · Jan 1987