Cleared Traditional

CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM (K970392) - FDA 510(k) Clearance

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

K970392 · Cordis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
80d
Days
Class 2
Risk

K970392 is an FDA 510(k) clearance for the CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on April 24, 1997 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cordis Corp. devices

Submission Details

510(k) Number K970392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1997
Decision Date April 24, 1997
Days to Decision 80 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
45d faster than avg
Panel avg: 125d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 32
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K970392.
MERIT PRELUDE SHEATH INTRODUCER
K050962 · Merit Medical Systems, Inc. · May 2005
MERIT MAK (MINI ACCESS KIT)
K031691 · Merit Medical Systems, Inc. · Sep 2003
COAXIAL DILATOR SET
K974640 · Boston Scientific Corp · Mar 1998
VESSEL DILATOR
K904476 · Datascope Corp. · Dec 1990
SHILEY FEMORAL CANNULAE INTRODUCER KIT
K881073 · Shiley, Inc. · Jun 1988
MODIFICATION OF TISSUE DILATOR
K862288 · Quinton, Inc. · Aug 1986