Cleared Traditional

K011646 - NEUROEDGE INFUSION CATHETER

K011646 is an FDA 510(k) clearance for NEUROEDGE INFUSION CATHETER, manufactured by Neuro Vasx, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K011646 · Neuro Vasx, Inc. · Cardiovascular device
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Aug 2001
Decision
90d
Days
Class 2
Risk

K011646 is an FDA 510(k) clearance for the NEUROEDGE INFUSION CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Neuro Vasx, Inc. (Maple Grove, US). The FDA issued a Cleared decision on August 27, 2001 after a review of 90 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 Neuro Vasx, Inc. devices

FDA 510(k) Submission Details - K011646

510(k) Number K011646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2001
Decision Date August 27, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 148
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K011646.
ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066
K024118 · Micro Therapeutics, Inc. · Feb 2003
PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
K021591 · Cordis Neurovascular, Inc. · May 2002
PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
K020680 · Cordis Neurovascular, Inc. · Mar 2002
FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065
K010004 · Micro Therapeutics, Inc. · Feb 2001
PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS
K003925 · Cordis Neurovascular, Inc. · Jan 2001
REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS
K002723 · Micro Therapeutics, Inc. · Sep 2000