Cleared Traditional

MODIFIED PEEL-AWAY INTRODUCER SET LINE (K864352) - FDA 510(k) Clearance

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

K864352 · Quinton, Inc. · Cardiovascular device
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Jan 1987
Decision
63d
Days
Class 2
Risk

K864352 is an FDA 510(k) clearance for the MODIFIED PEEL-AWAY INTRODUCER SET LINE. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on January 6, 1987 after a review of 63 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

Submission Details

510(k) Number K864352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1986
Decision Date January 06, 1987
Days to Decision 63 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
62d faster than avg
Panel avg: 125d · This submission: 63d
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 228
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K864352.
PULL-APART INTRODUCER (SHEATH)
K873727 · Quinton, Inc. · Oct 1987
OVAL PULL-APART SHEATH/DILATOR
K873394 · Quinton, Inc. · Sep 1987
MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH
K864705 · Quinton, Inc. · Feb 1987
CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST
K861082 · Cordis Corp. · May 1986
CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES
K855126 · Cordis Corp. · Feb 1986
MEDTRONIC PERMANENT LEAD INTRODUCER
K854559 · Medtronic Vascular · Dec 1985