Cleared Traditional

K992863 - LEAD STYLET

K992863 is the FDA 510(k) clearance for LEAD STYLET by Guidant Corp.. It is a Class 2 Cardiovascular device (product code DRB) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K992863 · Guidant Corp. · Cardiovascular device
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Nov 1999
Decision
79d
Days
Class 2
Risk

K992863 is an FDA 510(k) clearance for the LEAD STYLET,MODELS 6505,6506,6507,6508. Classified as Stylet, Catheter (product code DRB), Class II - Special Controls.

Submitted by Guidant Corp. (St Paul, US). The FDA issued a Cleared decision on November 12, 1999 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1380 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Guidant Corp. devices

Submission Details

510(k) Number K992863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1999
Decision Date November 12, 1999
Days to Decision 79 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
46d faster than avg
Panel avg: 125d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRB Stylet, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1380
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 - DRB Stylet, Catheter

All 13
Devices cleared under the same product code (DRB) and FDA review panel - the closest regulatory comparables to K992863.
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
K010906 · Medtronic Vascular · Apr 2001
STYLET KIT, MODELS 6254,6282,6293
K003535 · Medtronic Vascular · Feb 2001
PLACER MODEL 6232 STEERABLE STYLET
K000955 · Medtronic Vascular · Jun 2000
TARGET THERAPEUTICS RADIOPAQUE STYLET
K914001 · Target Therapeutics · Nov 1991
LEAD STYLET
K905674 · Cardiac Pacemakers, Inc. · Jan 1991
TUNNELING STYLET
K882097 · Quinton, Inc. · Jul 1988