Cleared Traditional

K013005 - ACT 11 MP VENTRICULAR CATHETER

K013005 is an FDA 510(k) clearance for ACT 11 MP VENTRICULAR CATHETER, manufactured by Innerspace, Inc.. The device is a Class 2 Neurology device with product code HCA cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K013005 · Innerspace, Inc. · Neurology device
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Mar 2002
Decision
183d
Days
Class 2
Risk

K013005 is an FDA 510(k) clearance for the ACT 11 MP VENTRICULAR CATHETER. Classified as Catheter, Ventricular (product code HCA), Class II - Special Controls.

Submitted by Innerspace, Inc. (Santa Ana, US). The FDA issued a Cleared decision on March 8, 2002 after a review of 183 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4100 - 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 Innerspace, Inc. devices

FDA 510(k) Submission Details - K013005

510(k) Number K013005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2001
Decision Date March 08, 2002
Days to Decision 183 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 148d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCA Device Classification - Class 2, Special Controls

Product Code HCA Catheter, Ventricular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4100
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 - HCA Catheter, Ventricular

Devices cleared under the same product code (HCA) and FDA review panel - the closest regulatory comparables to K013005.
CODMAN BACTISEAL BARIUM STRIPED CATHETERS
K031123 · Codman & Shurtleff, Inc. · May 2003
MIETHKE SHUNT SYSTEM
K020728 · Aesculap, Inc. · Apr 2002
CODMAN BACTISEAL CATHETERS
K003322 · Codman & Shurtleff, Inc. · Oct 2001
ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000
K992796 · Image-Guided Neurologics, Inc. · Oct 1999
DISPOS. SCOTT CANNULAS 16-1054 ETC.
K834477 · Codman & Shurtleff, Inc. · Mar 1984