Cleared Traditional

CORDIS BRITE TIP SHEATH INTRODUCER (K954595) - FDA 510(k) Clearance

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

K954595 · Cordis Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Dec 1995
Decision
86d
Days
Class 2
Risk

K954595 is an FDA 510(k) clearance for the CORDIS BRITE TIP 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 December 28, 1995 after a review of 86 days - a notably fast clearance cycle.

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: 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 K954595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1995
Decision Date December 28, 1995
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
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 K954595.
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K960406 · B.Braun Medical, Inc. · Apr 1996
BRAUN HEMOSTASIS INTRODUCERS
K955820 · B.Braun Medical, Inc. · Mar 1996
TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET
K955785 · C.R. Bard, Inc. · Mar 1996
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