Cleared Traditional

K043538 - HYPERTRANSIT INFUSION CATHETER

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

K043538 · Cordis Neurovascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K043538

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.

KRA Device Classification - Class 2, Special Controls

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 175
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K043538.
ECHELON MICRO CATHETER
K051990 · Micro Therapeutics, Inc. · Jan 2006
MIRA-FLEX 18 MICROCATHETER
K052841 · Cook, Inc. · Dec 2005
INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044
K052738 · Veinrx, Inc. · Dec 2005
PIVOT STEERABLE MICROCATHETER
K050630 · Boston Scientific - Precision Vascular · Mar 2005
BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH
K050205 · Flowmedica, Inc. · Mar 2005
ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90
K042187 · Micro Therapeutics, Inc. · Sep 2004
K043538 · HYPERTRANSIT INFUSION CATHETER
Download PDF FDA Summary Cordis Neurovascular,…