Cleared Traditional

K894250 - LE PTA CATHETER

K894250 is an FDA 510(k) clearance for LE PTA CATHETER, manufactured by Baxter Healthcare Corp. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K894250 · Baxter Healthcare Corp · Cardiovascular device
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Mar 1990
Decision
259d
Days
Class 2
Risk

K894250 is an FDA 510(k) clearance for the LE PTA CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on March 7, 1990 after a review of 259 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K894250

510(k) Number K894250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1989
Decision Date March 07, 1990
Days to Decision 259 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
134d slower than avg
Panel avg: 125d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 353
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K894250.
SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER
K902091 · Schneider Intl., Ltd. · Sep 1990
SMALL VESSEL BALLOON DILATATION CATHETER
K897124 · Boston Scientific Corp · Jul 1990
MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS
K901018 · Boston Scientific Corp · May 1990
ACCESSOR PERIPHERAL DILATING GUIDE WIRE
K895179 · Peripheral Systems Group · Feb 1990
EXPANSION OF THE CORDIS PTA DILATATION CATHETER
K894899 · Cordis Corp. · Jan 1990
BALLOON DILATATION CATHETER
K894944 · Peripheral Systems Group · Jan 1990