Cleared Traditional

K984214 - CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER

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

K984214 · Cordis Neurovascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K984214

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.

DXC Device Classification - Class 2, Special Controls

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 150
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K984214.
PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
K992174 · Pilling Weck Surgical · Mar 2000
AESCULAP VASCULAR INSTRUMENTS
K992053 · Aesculap, Inc. · Jan 2000
SLIMLINE SURGICAL CLAMP
K992640 · Minumys Surgical, Inc. · Sep 1999
FLEXIBLE VASCULAR CLAMP, VERSION 2
K991589 · Allegiance Healthcare Corp. · May 1999
ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT
K982365 · Geister Medizin Technik GmbH · Apr 1999
MICRINS MICRO ANASTOMOSIS CLAMP
K982278 · Micrins Surgical, Inc. · Mar 1999