Cleared Traditional

K873727 - PULL-APART INTRODUCER (SHEATH)

K873727 is an FDA 510(k) clearance for PULL-APART INTRODUCER (SHEATH), manufactured by Quinton, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K873727 · Quinton, Inc. · Cardiovascular device
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Oct 1987
Decision
28d
Days
Class 2
Risk

K873727 is an FDA 510(k) clearance for the PULL-APART INTRODUCER (SHEATH). Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on October 7, 1987 after a review of 28 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 Quinton, Inc. devices

FDA 510(k) Submission Details - K873727

510(k) Number K873727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1987
Decision Date October 07, 1987
Days to Decision 28 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

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 616
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K873727.
OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE
K882221 · Argon Medical Corp. · Aug 1988
ACS FUNNEL INTRODUCER
K875158 · Advanced Cardiovascular Systems, Inc. · May 1988
OLYMPUS ANGIOSCOPY SHEATH
K873100 · Olympus Corp. · Feb 1988
OVAL PULL-APART SHEATH/DILATOR
K873394 · Quinton, Inc. · Sep 1987
UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M
K871208 · Pacesetter Systems · Jun 1987
ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER
K871140 · Aries Medical, Inc. · Apr 1987