Cleared Traditional

CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS. (K863917) - FDA 510(k) Clearance

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

K863917 · Cardio-Vascular Innovations, Inc. · Cardiovascular device
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Jan 1987
Decision
90d
Days
Class 2
Risk

K863917 is an FDA 510(k) clearance for the CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS.. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cardio-Vascular Innovations, Inc. (Chantilly, US). The FDA issued a Cleared decision on January 6, 1987 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardio-Vascular Innovations, Inc. devices

Submission Details

510(k) Number K863917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1986
Decision Date January 06, 1987
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 272
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K863917.
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
MODIFIED PEEL-AWAY INTRODUCER SET LINE
K864352 · Quinton, Inc. · Jan 1987
TERUMO RADIFOCUS INTRODUCER KIT
K863139 · Terumo Medical Corp. · Oct 1986
CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST
K861082 · Cordis Corp. · May 1986