Cleared Traditional

K870189 - ARIES TAPERED SHEATH

K870189 is the FDA 510(k) clearance for ARIES TAPERED SHEATH by Aries Medical, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K870189 · Aries Medical, Inc. · Cardiovascular device
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Mar 1987
Decision
59d
Days
Class 2
Risk

K870189 is an FDA 510(k) clearance for the ARIES TAPERED SHEATH. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Aries Medical, Inc. (Woburn, US). The FDA issued a Cleared decision on March 16, 1987 after a review of 59 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 K870189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1987
Decision Date March 16, 1987
Days to Decision 59 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 125d · This submission: 59d
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 K870189.
PULL-APART INTRODUCER (SHEATH)
K873727 · Quinton, Inc. · Oct 1987
OVAL PULL-APART SHEATH/DILATOR
K873394 · Quinton, Inc. · Sep 1987
UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M
K871208 · Pacesetter Systems · Jun 1987
MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH
K864705 · Quinton, Inc. · Feb 1987
MODIFIED PEEL-AWAY INTRODUCER SET LINE
K864352 · Quinton, Inc. · Jan 1987
TERUMO RADIFOCUS INTRODUCER KIT
K863139 · Terumo Medical Corp. · Oct 1986