Cleared Traditional

K043538 - HYPERTRANSIT INFUSION CATHETER

K043538 is the FDA 510(k) clearance for HYPERTRANSIT INFUSION CATHETER by Cordis Neurovascular, Inc.. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K043538 · Cordis Neurovascular, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2005
Decision
117d
Days
Class 2
Risk

K043538 is an FDA 510(k) clearance for the HYPERTRANSIT INFUSION CATHETER. 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 April 18, 2005 after a review of 117 days - within the typical 510(k) review window.

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: 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 K043538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2004
Decision Date April 18, 2005
Days to Decision 117 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
8d faster than avg
Panel avg: 125d · This submission: 117d
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 K043538.
MODIFICATION TO MIRA-FLEX 18 MICROCATHETER
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MIRA-FLEX 18 MICROCATHETER
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K042187 · Micro Therapeutics, Inc. · Sep 2004
PROGREAT
K033913 · Terumo Medical Corp. · Mar 2004
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K034036 · Micro Therapeutics, Inc. · Feb 2004