Cleared Traditional

K233445 - Bactiseal Catheters

Also marketed or referenced as:
Bactiseal Barium Striped Catheters Bactiseal Endoscopic Ventricular Catheter

K233445 is an FDA 510(k) clearance for Bactiseal Catheters, manufactured by Integra Lifesciences Production Corporation. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K233445 · Integra Lifesciences Production Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
90d
Days
Class 2
Risk

K233445 is an FDA 510(k) clearance for the Bactiseal Catheters. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Integra Lifesciences Production Corporation (Mansfield, US). The FDA issued a Cleared decision on January 17, 2024 after a review of 90 days - within the typical 510(k) review window.

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 Integra Lifesciences Production Corporation devices

FDA 510(k) Submission Details - K233445

510(k) Number K233445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2023
Decision Date January 17, 2024
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
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 177
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K233445.
Duet External Drainage and Monitoring System (EDMS)
K243676 · Medtronic Neurosurgery · Mar 2025
XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set
K242003 · Aesculap, Inc. · Dec 2024
Borvo EVAC System (Ergo)
K241458 · Borvo Medical, Inc. · Aug 2024
Bactiseal EVD Catheter Sets
K233448 · Integra Lifesciences Production Corporation · Dec 2023
IRRAflow Active Fluid Exchange System (AFES)
K231664 · Irras USA, Inc. · Oct 2023
External Drainage System
K221694 · Jmed(Shenzhen) Technology Limited · Feb 2023