Cleared Traditional

Bactiseal EVD Catheter Sets (K233448) - FDA 510(k) Clearance

Also marketed or referenced as:
Bactiseal Clear EVD Catheter Set

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233448 · Integra Lifesciences Production Corporation · Neurology device
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Dec 2023
Decision
60d
Days
Class 2
Risk

K233448 is an FDA 510(k) clearance for the Bactiseal EVD Catheter Sets. 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 December 19, 2023 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Integra Lifesciences Production Corporation devices

Submission Details

510(k) Number K233448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2023
Decision Date December 19, 2023
Days to Decision 60 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
88d faster than avg
Panel avg: 148d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 94
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K233448.
XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set
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