Cleared Traditional

K903442 - ARIES TAPERSEAL(TM) SHEATH

K903442 is the FDA 510(k) clearance for ARIES TAPERSEAL(TM) SHEATH by Aries Medical, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K903442 · Aries Medical, Inc. · Cardiovascular device
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Aug 1990
Decision
23d
Days
Class 2
Risk

K903442 is an FDA 510(k) clearance for the ARIES TAPERSEAL(TM) SHEATH. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Aries Medical, Inc. (Chelmsford, US). The FDA issued a Cleared decision on August 23, 1990 after a review of 23 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 Aries Medical, Inc. devices

Submission Details

510(k) Number K903442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1990
Decision Date August 23, 1990
Days to Decision 23 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 125d · This submission: 23d
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 325
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K903442.
ENTREE SHEATH INTRODUCER SYSTEM
K904475 · Cordis Corp. · Apr 1991
DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABL
K902932 · Datascope Corp. · Oct 1990
MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S)
K900515 · Medtronic Vascular · Aug 1990
DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER
K901391 · Datascope Corp. · Jun 1990
USCI(R) ACCESS(TM) INTRODUCER SET
K901452 · C.R. Bard, Inc. · May 1990
HEMAQUET(TM) AND HEMAFLEX(TM) INTRODUCERS
K897041 · C.R. Bard, Inc. · Mar 1990