Cleared Traditional

K970392 - CORDIS AVANTI+CATHETER SHEATH INTRODUCE...

K970392 is an FDA 510(k) clearance for CORDIS AVANTI+CATHETER SHEATH INTRODUCE..., manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 80-day FDA review.

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

FDA 510(k) Submission Details - K970392

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.

DRE Device Classification - Class 2, Special Controls

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 50
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K970392.
MERIT MAK (MINI ACCESS KIT)
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FLEXIBLE DILATING SHEATH
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VESSEL DILATOR
K963388 · Maxxim Medical · Mar 1997
WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI)
K914555 · Med Institute, Inc. · Jan 1992