Cleared Traditional

K890405 - USCI PTA BALLOON DILATATION CATHETER

K890405 is the FDA 510(k) clearance for USCI PTA BALLOON DILATATION CATHETER by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K890405 · C.R. Bard, Inc. · Cardiovascular device
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Aug 1989
Decision
205d
Days
Class 2
Risk

K890405 is an FDA 510(k) clearance for the USCI PTA BALLOON DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on August 17, 1989 after a review of 205 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K890405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1989
Decision Date August 17, 1989
Days to Decision 205 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
80d slower than avg
Panel avg: 125d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 238
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K890405.
LE PTA CATHETER
K894250 · Baxter Healthcare Corp · Mar 1990
EXPANSION OF THE CORDIS PTA DILATATION CATHETER
K894899 · Cordis Corp. · Jan 1990
STEALTH DILATION CATHETER SYSTEM
K893411 · Target Therapeutics · Sep 1989
ROTATING HEMOSTATIC VALVE
K890800 · Datascope Corp. · Jun 1989
USCI DISP. Y-CONNECTOR W/MODIFIED TUOHY-BORST ADAP
K890325 · C.R. Bard, Inc. · Mar 1989
STANDARD, TUOHY BORST & DUAL VALVE Y-CONNECTOR
K885247 · Baxter Healthcare Corp · Mar 1989