Cleared Traditional

K941428 - EXACTA PERCUTANEOUS INTRODUCER SHEATH

K941428 is an FDA 510(k) clearance for EXACTA PERCUTANEOUS INTRODUCER SHEATH, manufactured by Ohmeda Medical. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K941428 · Ohmeda Medical · Cardiovascular device
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Jul 1994
Decision
104d
Days
Class 2
Risk

K941428 is an FDA 510(k) clearance for the EXACTA PERCUTANEOUS INTRODUCER SHEATH. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Ohmeda Medical (Oxnard, US). The FDA issued a Cleared decision on July 6, 1994 after a review of 104 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 Ohmeda Medical devices

FDA 510(k) Submission Details - K941428

510(k) Number K941428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1994
Decision Date July 06, 1994
Days to Decision 104 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
21d faster than avg
Panel avg: 125d · This submission: 104d
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 K941428.
ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903
K940079 · Arrow Intl., Inc. · Nov 1994
URESIL DILATOR
K942191 · Uresil Corp. · Sep 1994
VIP PLUS PERCUTANEOUS INTRODUCER
K944107 · Medamicus, Inc. · Sep 1994
CATH-SEAL
K935077 · Universal Medical Instrument Corp. · Jun 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