Cleared Special

K001346 - ULTIMUM HEMOSTASIS INTRODUCER

K001346 is an FDA 510(k) clearance for ULTIMUM HEMOSTASIS INTRODUCER, manufactured by St. Jude Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 26-day FDA review.

K001346 · St. Jude Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
26d
Days
Class 2
Risk

K001346 is an FDA 510(k) clearance for the ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by St. Jude Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on May 24, 2000 after a review of 26 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, Inc. devices

FDA 510(k) Submission Details - K001346

510(k) Number K001346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2000
Decision Date May 24, 2000
Days to Decision 26 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
99d faster than avg
Panel avg: 125d · This submission: 26d
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 468
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K001346.
DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET
K002365 · Datascope Corp. · Aug 2000
6F & 7F INTRODUCING CATHETERS (MODIFICATION)
K001135 · Cordis Corp. · Jul 2000
FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX
K001367 · St. Jude Medical, Inc. · May 2000
ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX
K994334 · Daig Corp. · 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