Cleared Traditional

K081472 - SMARTPORT CT VORTEX

Also marketed or referenced as:
LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS

K081472 is an FDA 510(k) clearance for SMARTPORT CT VORTEX, manufactured by AngioDynamics, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K081472 · AngioDynamics, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
119d
Days
Class 2
Risk

K081472 is an FDA 510(k) clearance for the SMARTPORT CT VORTEX. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on September 23, 2008 after a review of 119 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K081472

510(k) Number K081472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2008
Decision Date September 23, 2008
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 129d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJT Device Classification - Class 2, Special Controls

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
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 General Hospital devices follow this clearance model.

Regulatory Peers - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 285
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K081472 · SMARTPORT CT VORTEX
Download PDF FDA Summary AngioDynamics, Inc.