Cleared Traditional

K942191 - URESIL DILATOR

K942191 is an FDA 510(k) clearance for URESIL DILATOR, manufactured by Uresil Corp.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K942191 · Uresil Corp. · Cardiovascular device
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Sep 1994
Decision
140d
Days
Class 2
Risk

K942191 is an FDA 510(k) clearance for the URESIL DILATOR. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on September 21, 1994 after a review of 140 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. 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 Uresil Corp. devices

FDA 510(k) Submission Details - K942191

510(k) Number K942191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1994
Decision Date September 21, 1994
Days to Decision 140 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 125d · This submission: 140d
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 435
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K942191.
CORDIS AVANTI CATHETER SHEATH INTRODUCER
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ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903
K940079 · Arrow Intl., Inc. · Nov 1994
EXACTA PERCUTANEOUS INTRODUCER SHEATH
K941428 · Ohmeda Medical · Jul 1994
ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE
K934624 · Advanced Cardiovascular Systems, Inc. · Apr 1994
TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE
K934901 · Thomas Medical Products, Inc. · Jan 1994