Cleared Traditional

K984214 - CORDIS ENDOVASCULAR TEMPORARY OCCLUSION...

K984214 is the FDA 510(k) clearance for CORDIS ENDOVASCULAR TEMPORARY OCCLUSION... by Cordis Neurovascular, Inc.. It is a Class 2 Cardiovascular device (product code DXC) cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K984214 · Cordis Neurovascular, Inc. · Cardiovascular device
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Aug 1999
Decision
259d
Days
Class 2
Risk

K984214 is an FDA 510(k) clearance for the CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Cordis Neurovascular, Inc. (Miami Lake, US). The FDA issued a Cleared decision on August 10, 1999 after a review of 259 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Cordis Neurovascular, Inc. devices

Submission Details

510(k) Number K984214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1998
Decision Date August 10, 1999
Days to Decision 259 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
134d slower than avg
Panel avg: 125d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - DXC Clamp, Vascular

All 59
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K984214.
KSEA DION-GRACIA SET
K010785 · KARL STORZ Endoscopy-America, Inc. · Aug 2001
MALLEABLE SHAFT CLAMP
K011078 · Allegiance Healthcare Corp. · Jul 2001
AESCULAP VASCULAR INSTRUMENTS
K992053 · Aesculap, Inc. · Jan 2000
FLEXIBLE VASCULAR CLAMP, VERSION 2
K991589 · Allegiance Healthcare Corp. · May 1999
COSGROVE CLAMP
K974769 · Allegiance Healthcare Corp. · Jun 1998
SURGICAL VASCULAR CLAMP
K973080 · Walter Lorenz Surgical, Inc. · Feb 1998