Cleared Traditional

K983830 - COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER

K983830 is an FDA 510(k) clearance for COPPERHEAD 5 FR. PTA CATHETER, manufactured by Mallinckroot, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K983830 · Mallinckroot, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
168d
Days
Class 2
Risk

K983830 is an FDA 510(k) clearance for the COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Mallinckroot, Inc. (St Louis, US). The FDA issued a Cleared decision on April 16, 1999 after a review of 168 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 Mallinckroot, Inc. devices

FDA 510(k) Submission Details - K983830

510(k) Number K983830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1998
Decision Date April 16, 1999
Days to Decision 168 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 125d · This submission: 168d
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 K983830.
WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
K991540 · AngioDynamics, Inc. · Sep 1999
CORDIS EXTREME PTA BALLOON CATHETER
K992825 · Cordis Corp. · Sep 1999
CORDIS MAXI DS PTA BALLOON CATHETER
K991811 · Cordis Corp. · Jun 1999
BIPORE BALLOON DILATATION CATHETER
K983650 · Bipore, Inc. · Feb 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
PTA BALLOON CATHETER
K980390 · Cook, Inc. · Aug 1998