Cleared Traditional

MORSE VASCULAR INTRODUCER SET (K912961) - FDA 510(k) Clearance

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

K912961 · North American Instrument Corp. · Cardiovascular device
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Sep 1991
Decision
65d
Days
Class 2
Risk

K912961 is an FDA 510(k) clearance for the MORSE VASCULAR INTRODUCER SET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by North American Instrument Corp. (Glens Falls, US). The FDA issued a Cleared decision on September 11, 1991 after a review of 65 days - a notably fast clearance cycle.

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: 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 North American Instrument Corp. devices

Submission Details

510(k) Number K912961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1991
Decision Date September 11, 1991
Days to Decision 65 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 125d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 259
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K912961.
USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING
K915553 · C.R. Bard, Inc. · Feb 1992
CORDIS OBTURATOR
K914352 · Cordis Corp. · Nov 1991
CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL
K913801 · Cordis Corp. · Oct 1991
CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE
K911794 · Cordis Corp. · Jul 1991
MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS
K911236 · Medtronic Vascular · Jun 1991
OLYMPUS ANGIOSCOPY IRRIGATION SHEATH
K910933 · Olympus Corp. · Jun 1991