Cleared Traditional

K890405 - USCI PTA BALLOON DILATATION CATHETER

K890405 is an FDA 510(k) clearance for USCI PTA BALLOON DILATATION CATHETER, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K890405

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.

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 345
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K890405.
EXPANSION OF THE CORDIS PTA DILATATION CATHETER
K894899 · Cordis Corp. · Jan 1990
BALLOON DILATATION CATHETER
K894944 · Peripheral Systems Group · 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