Cleared Traditional

K915078 - MORSE HEMOSTATIC CATHETER INTRODUCER SET

K915078 is the FDA 510(k) clearance for MORSE HEMOSTATIC CATHETER INTRODUCER SET by North American Instrument Corp.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K915078 · North American Instrument Corp. · Cardiovascular device
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Jun 1992
Decision
215d
Days
Class 2
Risk

K915078 is an FDA 510(k) clearance for the MORSE HEMOSTATIC CATHETER 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 June 10, 1992 after a review of 215 days - an extended review 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: 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 North American Instrument Corp. devices

Submission Details

510(k) Number K915078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1991
Decision Date June 10, 1992
Days to Decision 215 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 125d · This submission: 215d
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 405
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K915078.
OVER THE NEEDLE SPLITABLE CATHETER W/FUNNEL LOCATO
K920907 · Teleflexmedical, Inc. · Oct 1992
OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 1
K920908 · Teleflexmedical, Inc. · Oct 1992
CATHETER INTRODUCER
K920528 · Boston Scientific Corp · Aug 1992
INTRODUCER CATHETER
K915625 · Interventional Therapeutics Corp. · Jun 1992
FAST-CATH HEMOSTASIS INTRODUCER
K920779 · Daig Corp. · Jun 1992
GORE TUNNELER, MODIFICATION
K920998 · W.L. Gore & Associates, Inc. · Jun 1992