Cleared Traditional

K033017 - PHOENIX INFUSION CATHETER

K033017 is an FDA 510(k) clearance for PHOENIX INFUSION CATHETER, manufactured by Phoenix Biomedical. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K033017 · Phoenix Biomedical · Neurology device
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Apr 2004
Decision
194d
Days
Class 2
Risk

K033017 is an FDA 510(k) clearance for the PHOENIX INFUSION CATHETER. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Phoenix Biomedical (Valley Forge, US). The FDA issued a Cleared decision on April 7, 2004 after a review of 194 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Phoenix Biomedical devices

FDA 510(k) Submission Details - K033017

510(k) Number K033017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2003
Decision Date April 07, 2004
Days to Decision 194 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 148d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXG Device Classification - Class 2, Special Controls

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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 Neurology devices follow this clearance model.

Regulatory Peers - JXG Shunt, Central Nervous System And Components

All 214
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K033017.
PS MEDICAL NEUROSURGICAL IMPLANTS
K042198 · Medtronic Neurosurgery · Sep 2004
MEDTRONIC PS MEDICAL STRATA VALVE
K040943 · Medtronic Neurosurgery · Jun 2004
MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI
K041296 · Codman & Shurtleff, Inc. · Jun 2004
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE
K033850 · Medtronic Neurosurgery · Jan 2004
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
K031303 · Aesculap, Inc. · Jun 2003
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV
K030698 · Aesculap, Inc. · Mar 2003