Cleared Traditional

K911236 - MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS

K911236 is an FDA 510(k) clearance for MEDTRONIC PERMANENT LEAD INTRODUCER, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K911236 · Medtronic Vascular · Cardiovascular device
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Jun 1991
Decision
90d
Days
Class 2
Risk

K911236 is an FDA 510(k) clearance for the MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on June 18, 1991 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Medtronic Vascular devices

FDA 510(k) Submission Details - K911236

510(k) Number K911236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1991
Decision Date June 18, 1991
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 611
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K911236.
CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL
K913801 · Cordis Corp. · Oct 1991
MORSE VASCULAR INTRODUCER SET
K912961 · North American Instrument Corp. · Sep 1991
CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE
K911794 · Cordis Corp. · Jul 1991
OLYMPUS ANGIOSCOPY IRRIGATION SHEATH
K910933 · Olympus Corp. · Jun 1991
CORDIS PEEL-AWAY INSERTION TOOL
K910688 · Cordis Corp. · May 1991
PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK
K910861 · Daig Corp. · May 1991