Cleared Traditional

LEAD STYLET (K905674) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K905674 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Jan 1991
Decision
43d
Days
Class 2
Risk

K905674 is an FDA 510(k) clearance for the LEAD STYLET. Classified as Stylet, Catheter (product code DRB), Class II - Special Controls.

Submitted by Cardiac Pacemakers, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 30, 1991 after a review of 43 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 Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K905674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1990
Decision Date January 30, 1991
Days to Decision 43 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 125d · This submission: 43d
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 27
Devices cleared under the same product code (DRB) and FDA review panel - the closest regulatory comparables to K905674.
Arrow Stiffening Stylet
K220280 · Arrow International, LLC (A subsidiary of Teleflex, Inc.) · Aug 2022
Biotronik Stylets
K191469 · Biotronik, Inc. · Aug 2019
GaltTWS
K182660 · Galt Medical Corp. · May 2019
Liberator Beacon Tip Locking Stylet
K170298 · Cook Incorporated · Oct 2017
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
K010906 · Medtronic Vascular · Apr 2001
STYLET KIT, MODELS 6254,6282,6293
K003535 · Medtronic Vascular · Feb 2001