Cleared Traditional

K963886 - EVS

K963886 is an FDA 510(k) clearance for EVS, manufactured by Applied Medical Resources. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K963886 · Applied Medical Resources · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
210d
Days
Class 2
Risk

K963886 is an FDA 510(k) clearance for the EVS. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on April 24, 1997 after a review of 210 days - an extended review 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: 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 Applied Medical Resources devices

FDA 510(k) Submission Details - K963886

510(k) Number K963886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1996
Decision Date April 24, 1997
Days to Decision 210 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 125d · This submission: 210d
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 447
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K963886.
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K971608 · Cordis Corp. · Jul 1997
FAST-CATH TRANSSEPTAL CATHETER INTRODUCER
K964518 · Daig Corp. · May 1997
TRANSJUGULAR ACCESS SET
K964034 · AngioDynamics, Inc. · May 1997
CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM
K962978 · Johnson & Johnson Medical, Inc. · Jan 1997
HEMODIALYSIS INTRODUCER SET
K961780 · Thomas Medical Products, Inc. · Dec 1996
CATH SEAL
K962180 · Universal Medical Instrument Corp. · Nov 1996