Cleared Traditional

K991540 - WORKHORSE PERCUTANEOUS TRANSLUMINAL ANG...

K991540 is the FDA 510(k) clearance for WORKHORSE PERCUTANEOUS TRANSLUMINAL ANG... by AngioDynamics, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K991540 · AngioDynamics, Inc. · Cardiovascular device
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Sep 1999
Decision
149d
Days
Class 2
Risk

K991540 is an FDA 510(k) clearance for the WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on September 29, 1999 after a review of 149 days - within the typical 510(k) review window.

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 AngioDynamics, Inc. devices

Submission Details

510(k) Number K991540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1999
Decision Date September 29, 1999
Days to Decision 149 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 125d · This submission: 149d
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 K991540.
TRANSLUMINAL BALLOON DILATATION CATHETER
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RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
K993639 · Guidant Corp. · Jan 2000
CORDIS EXTREME PTA BALLOON CATHETER
K992825 · Cordis Corp. · Sep 1999
CORDIS MAXI DS PTA BALLOON CATHETER
K991811 · Cordis Corp. · Jun 1999
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003
K983055 · Guidant Corp. · Dec 1998