Cleared Special

K994334 - ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL...

K994334 is the FDA 510(k) clearance for ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL... by Daig Corp.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Special 510(k) pathway after a 144-day FDA review.

K994334 · Daig Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2000
Decision
144d
Days
Class 2
Risk

K994334 is an FDA 510(k) clearance for the ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Daig Corp. (Minnetonka, US). The FDA issued a Cleared decision on May 15, 2000 after a review of 144 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Daig Corp. devices

Submission Details

510(k) Number K994334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1999
Decision Date May 15, 2000
Days to Decision 144 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
19d slower than avg
Panel avg: 125d · This submission: 144d
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 398
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K994334.
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
6F & 7F INTRODUCING CATHETERS (MODIFICATION)
K001135 · Cordis Corp. · Jul 2000
PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
K001139 · Biosense Webster, Inc. · May 2000
IN-LINE HEMOSTASIS VALVE
K990975 · Merit Medical Systems, Inc. · Mar 2000
INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE
K994252 · Boston Scientific Corp · Jan 2000