Cleared Special

K994334 - ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX

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

K994334 · Daig Corp. · Cardiovascular device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K994334

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.

DYB Device Classification - Class 2, Special Controls

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 617
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K994334.
FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX
K001367 · St. Jude Medical, Inc. · May 2000
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)
K992668 · Innerdyne, Inc. · May 2000
ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX
K001346 · St. Jude Medical, Inc. · May 2000
PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
K001139 · Biosense Webster, Inc. · May 2000
PERCUTANEOUS INTRODUCER, MODEL 10383-XXX
K000824 · Medamicus, Inc. · Apr 2000
TFX MEDICAL INTRODUCER ASSEMBLY
K993191 · Tfx Medical, Inc. · Mar 2000