Cleared Special

K003729 - ULTIMUM EV HEMOSTASIS INTRODUCER (14F)

K003729 is the FDA 510(k) clearance for ULTIMUM EV HEMOSTASIS INTRODUCER (14F) by St Jude Medical. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Special 510(k) pathway after a 30-day FDA review.

K003729 · St Jude Medical · Cardiovascular device
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Jan 2001
Decision
30d
Days
Class 2
Risk

K003729 is an FDA 510(k) clearance for the ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F.... Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by St Jude Medical (Minnetonka, US). The FDA issued a Cleared decision on January 3, 2001 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all St Jude Medical devices

Submission Details

510(k) Number K003729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2000
Decision Date January 03, 2001
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 396
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K003729.
MICROCRUISER PLUS INTRODUCER SET
K011790 · Medical Device Technologies, Inc. · Sep 2001
TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT
K002507 · Arrow Intl., Inc. · Mar 2001
INTRODEUCE DOUBLE LUMEN INTRODUCER
K001985 · Cook, Inc. · Jan 2001
ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509
K000004 · Daig Corp. · Nov 2000
PINNACLE R/O II OR RADIFOCUS INTRODUCER II
K003424 · Terumo Medical Corp. · Nov 2000
DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET
K002365 · Datascope Corp. · Aug 2000