Cleared Traditional

K945616 - CORDIS AVANTI CATHETER SHEATH INTRODUCER

K945616 is an FDA 510(k) clearance for CORDIS AVANTI CATHETER SHEATH INTRODUCER, manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K945616 · Cordis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K945616

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.

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 438
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
URESIL DILATOR
K942191 · Uresil Corp. · Sep 1994