Cleared Traditional

MICROCRUISER PLUS INTRODUCER SET (K011790) - FDA 510(k) Clearance

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

K011790 · Medical Device Technologies, Inc. · Cardiovascular device
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Sep 2001
Decision
89d
Days
Class 2
Risk

K011790 is an FDA 510(k) clearance for the MICROCRUISER PLUS INTRODUCER SET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Medical Device Technologies, Inc. (Gainesville, US). The FDA issued a Cleared decision on September 5, 2001 after a review of 89 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 Medical Device Technologies, Inc. devices

Submission Details

510(k) Number K011790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2001
Decision Date September 05, 2001
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
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 K011790.
INTROCAN SAFETY IV CATHETER
K021094 · B.Braun Medical, Inc. · Jul 2002
RENAL GUIDING SHEATH
K012854 · Terumo Medical Corp. · Nov 2001
CAROTID GUIDING SHEATH
K012812 · Terumo Medical Corp. · Nov 2001
INTRODEUCE DOUBLE LUMEN INTRODUCER
K001985 · Cook, Inc. · Jan 2001
PINNACLE R/O II OR RADIFOCUS INTRODUCER II
K003424 · Terumo Medical Corp. · Nov 2000
6F & 7F INTRODUCING CATHETERS (MODIFICATION)
K001135 · Cordis Corp. · Jul 2000