Cleared Traditional

K001985 - INTRODEUCE DOUBLE LUMEN INTRODUCER

K001985 is an FDA 510(k) clearance for INTRODEUCE DOUBLE LUMEN INTRODUCER, manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K001985 · Cook, Inc. · Cardiovascular device
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Jan 2001
Decision
210d
Days
Class 2
Risk

K001985 is an FDA 510(k) clearance for the INTRODEUCE DOUBLE LUMEN INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on January 25, 2001 after a review of 210 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook, Inc. devices

FDA 510(k) Submission Details - K001985

510(k) Number K001985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2000
Decision Date January 25, 2001
Days to Decision 210 days
Submission Type Traditional
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
85d slower than avg
Panel avg: 125d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 598
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K001985.
INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX
K002847 · Maxxim Medical · May 2001
SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE
K003731 · Thomas Medical Products, Inc. · Apr 2001
TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT
K002507 · Arrow Intl., Inc. · Mar 2001
ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F),
K003729 · St Jude Medical · 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