Cleared Traditional

K954949 - TRANSIT INFUSION CATHETER WITH SIDEHOLES

K954949 is the FDA 510(k) clearance for TRANSIT INFUSION CATHETER WITH SIDEHOLES by Cordis Neurovascular, Inc.. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K954949 · Cordis Neurovascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
53d
Days
Class 2
Risk

K954949 is an FDA 510(k) clearance for the TRANSIT INFUSION CATHETER WITH SIDEHOLES. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Cordis Neurovascular, Inc. (Miami Lakes, US). The FDA issued a Cleared decision on December 22, 1995 after a review of 53 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cordis Neurovascular, Inc. devices

Submission Details

510(k) Number K954949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1995
Decision Date December 22, 1995
Days to Decision 53 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
72d faster than avg
Panel avg: 125d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K954949.
MX703 AND MX730 CONTINUOUS FLUSH DEVICES
K961527 · Medex, Inc. · Jun 1996
SCIMED DISPATCH CORONARY INFUSION CATHETER
K953133 · Scimed Life Systems, Inc. · Feb 1996
MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE
K954020 · Micro Therapeutics, Inc. · Jan 1996
TRANSIT INFUSION CATHETER
K952874 · Cordis Neurovascular, Inc. · Aug 1995
SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER
K952872 · Scimed Life Systems, Inc. · Jul 1995
EVOLUTION(TM) MICROCATHETER
K945666 · Boston Scientific Corp · Jun 1995