Cleared Traditional

CORDIS AVANTI CATHETER SHEATH INTRODUCER (K945616) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K945616 · Cordis Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 1995
Decision
134d
Days
Class 2
Risk

K945616 is an FDA 510(k) clearance for the CORDIS AVANTI CATHETER SHEATH INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on March 29, 1995 after a review of 134 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 Cordis Corp. devices

Submission Details

510(k) Number K945616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1994
Decision Date March 29, 1995
Days to Decision 134 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
9d slower than avg
Panel avg: 125d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 284
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K945616.
RADIFOCUS INTRODUCER II KIT
K954234 · Terumo Medical Corp. · Nov 1995
MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM
K952828 · Boston Scientific Corp · Aug 1995
CORDIS INTRODUCING CATHETER
K945524 · Cordis Corp. · Apr 1995
FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET
K945396 · B.Braun Medical, Inc. · Mar 1995
ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903
K940079 · Arrow Intl., Inc. · Nov 1994
EXACTA PERCUTANEOUS INTRODUCER SHEATH
K941428 · Ohmeda Medical · Jul 1994