Cleared Special

K983003 - 1 MASS TRANSIT INFUSION CATHETER

K983003 is the FDA 510(k) clearance for 1 MASS TRANSIT INFUSION CATHETER by Cordis Neurovascular, Inc.. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Special 510(k) pathway after a 20-day FDA review.

K983003 · Cordis Neurovascular, Inc. · Cardiovascular device
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Sep 1998
Decision
20d
Days
Class 2
Risk

K983003 is an FDA 510(k) clearance for the 1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Cordis Neurovascular, Inc. (Miami Lake, US). The FDA issued a Cleared decision on September 17, 1998 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cordis Neurovascular, Inc. devices

Submission Details

510(k) Number K983003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1998
Decision Date September 17, 1998
Days to Decision 20 days
Submission Type Special
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
105d faster than avg
Panel avg: 125d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 - KRA Catheter, Continuous Flush

All 124
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K983003.
RENEGADE HI-FLO MICROCATHETER
K000177 · Boston Scientific Corp · Apr 2000
REBAR MICRO CATHETER, MODELS 105-5080, 105-5086
K993672 · Micro Therapeutics, Inc. · Jan 2000
PROWLER PLUS INFUSION CATHETER
K993266 · Cordis Neurovascular, Inc. · Oct 1999
EASY RIDER MICRO CATHETER
K974473 · Micro Therapeutics, Inc. · Jun 1998
FLOW RIDER FLOW DIRECTED MICRO CATHETER
K980104 · Micro Therapeutics, Inc. · Apr 1998
CES MASSTRANSIT INFUSION CATHETER
K974222 · Cordis Neurovascular, Inc. · Feb 1998