Cleared Traditional

CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL (K913801) - FDA 510(k) Clearance

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

K913801 · Cordis Corp. · Cardiovascular device
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Oct 1991
Decision
51d
Days
Class 2
Risk

K913801 is an FDA 510(k) clearance for the CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL. 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 October 16, 1991 after a review of 51 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 K913801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1991
Decision Date October 16, 1991
Days to Decision 51 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 125d · This submission: 51d
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 K913801.
USCI HEMAQUET XT INTRODUCER
K920251 · C.R. Bard, Inc. · Mar 1992
USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING
K915553 · C.R. Bard, Inc. · Feb 1992
CORDIS OBTURATOR
K914352 · Cordis Corp. · Nov 1991
CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE
K911794 · Cordis Corp. · Jul 1991
MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS
K911236 · Medtronic Vascular · Jun 1991
OLYMPUS ANGIOSCOPY IRRIGATION SHEATH
K910933 · Olympus Corp. · Jun 1991